Corcym Inc.
Saluggia (VC) Vercelli, IT
Corcym Inc. appears in FDA device records in Saluggia (VC) Vercelli, IT. FDA records list 64 510(k) clearances between and , 99 PMA records and 4 registered establishments. As of , FDA records show 15 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Corcym Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- MicroPort CRM S.r.l.registration
- Sorin Group Italia S.R.L.registration, 510(k), enforcement report, recall
- Sorin Group Italia SRL - CRFenforcement report, recall
510(k) clearance history
Showing 50 of 64FDA records hold 64 510(k) clearances for Corcym Inc. between 1995 and 2026. The busiest year on record is 2012, with 7. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 2001 | 2 |
| 2003 | 1 |
| 2006 | 2 |
| 2007 | 3 |
| 2008 | 3 |
| 2009 | 3 |
| 2010 | 4 |
| 2011 | 3 |
| 2012 | 7 |
| 2013 | 3 |
| 2014 | 1 |
| 2015 | 2 |
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 2 |
| 2020 | 3 |
| 2021 | 1 |
| 2023 | 3 |
| 2024 | 5 |
| 2025 | 5 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261707 | MEMO 4D Curve™ Semirigid mitral annuloplasty ring | KRH | Substantially Equivalent | |
| K260498 | TriMemo™ SEMIRIGID ANNULOPLASTY RING | KRH | Substantially Equivalent | |
| K253671 | Dual Stage Venous Cannulae | DWF | Substantially Equivalent | |
| K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirs | DTN | Substantially Equivalent | |
| K253616 | ProtekDilate Vascular Access Kit | DRE | Substantially Equivalent | |
| K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | DWF | Substantially Equivalent | |
| K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) | DTR | Substantially Equivalent | |
| K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) | KDI | Substantially Equivalent | |
| K242953 | KIDS Arterial Filters | DTM | Substantially Equivalent | |
| K242092 | MICRO Arterial Filters | DTM | Substantially Equivalent | |
| K241236 | XTRA Collection sets; XTRA Sequestration set X | CAC | Substantially Equivalent | |
| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets) | CAC | Substantially Equivalent | |
| K240193 | R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) | DWF | Substantially Equivalent | |
| K231652 | D100 KIDS; D101 KIDS | DTZ | Substantially Equivalent | |
| K223361 | BMR 1900 PHISIO | DTN | Substantially Equivalent | |
| K230318 | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring | KRH | Substantially Equivalent | |
| K211495 | EOS PMP | DTZ | Substantially Equivalent | |
| K200612 | R501 aortic root cannula without vent line, R502 aortic root cannula with vent line | DWF | Substantially Equivalent | |
| K201916 | Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator | DTZ | Substantially Equivalent | |
| K200683 | INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir | DTZ | Substantially Equivalent | |
| K190650 | Revolution Centrifugal Blood Pump | KFM | Substantially Equivalent | |
| K190690 | INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir | DTZ | Substantially Equivalent | |
| K180979 | PureFlex Arterial Cannulae | DWF | Substantially Equivalent | |
| K180411 | MEMO 4D | KRH | Substantially Equivalent | |
| K180448 | INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter | DTZ | Substantially Equivalent | |
| K162215 | Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae | DWF | Substantially Equivalent | |
| K161733 | INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C | DTN | Substantially Equivalent | |
| K151713 | LILLIPUP PMP, LILLIPUT PMP INTEGRATED | DTZ | Substantially Equivalent | |
| K150489 | EOS PMP, EOS PMP Integrated | DTZ | Substantially Equivalent | |
| K142221 | MEMO 3D ReChord | KRH | Substantially Equivalent | |
| K131103 | XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR | DTN | Substantially Equivalent | |
| K130433 | INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE | DTZ | Substantially Equivalent | |
| K130209 | INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED | DTZ | Substantially Equivalent | |
| K122844 | INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR | DTZ | Substantially Equivalent | |
| K122254 | INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR | DTZ | Substantially Equivalent | |
| K121536 | INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR | DTZ | Substantially Equivalent | |
| K121909 | INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR | DTZ | Substantially Equivalent | |
| K121229 | INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY | DTZ | Substantially Equivalent | |
| K120185 | INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR | DTZ | Substantially Equivalent | |
| K113626 | INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR | DTZ | Substantially Equivalent | |
| K112771 | BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG | DTN | Substantially Equivalent | |
| K112245 | XTRA | CAC | Substantially Equivalent | |
| K110782 | XVAC | CAC | Substantially Equivalent | |
| K103202 | PREASSEMBLED SURGICAL WASH SET | CAC | Substantially Equivalent | |
| K101586 | XTRA AUTOTRANSFUSION SYSTEM | CAC | Substantially Equivalent | |
| K100507 | XRES BLOOD COLLECTION RESERVOIR | DTN | Substantially Equivalent | |
| K093986 | AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS | DTM | Substantially Equivalent | |
| K093601 | AF 840 PH.I.S.I.O. ARTERIAL FILTER | DTM | Substantially Equivalent | |
| K092895 | APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR | DTZ | Substantially Equivalent | |
| K092315 | SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR | DTN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3019892983 | 3019892983 | Corcym Inc. | 9800 Mount Pyramid Court, Suite #400, Englewood, CO 80112 US | 2026 | |
| 3005687633 | 3005687633 | Corcym S.r.l. | VIA CRESCENTINO, SN, SALUGGIA Vercelli 13040 IT | 2026 | |
| 1000165971 | 1000165971 | MicroPort CRM S.r.l. | Via Crescentino s.n, Saluggia (VC) Vercelli 13040 IT | 2026 | and 2 more, listed in full below |
| 9680841 | 3005426550 | SORIN GROUP ITALIA S.R.L | 86, VIA STATALE 12 NORD, MIRANDOLA Modena 41037 IT | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KRIAccessory Equipment, Cardiopulmonary Bypass
- PSTAortic Annuloplasty Ring
- CACApparatus, Autotransfusion
- DQRCannula, Catheter
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DXCClamp, Vascular
- DQKComputer, Diagnostic, Programmable
- DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass
- NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
- MRMDefibrillator, Implantable, Dual-Chamber
- DTPDefoamer, Cardiopulmonary Bypass
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- DREDilator, Vessel, For Percutaneous Catheterization
- NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
- PZSDual Lumen Ecmo Cannula
- MWJElectrocardiograph, Ambulatory (Without Analysis)
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- LWQHeart-Valve, Mechanical
- LWRHeart-Valve, Non-Allograft Tissue
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- DTJHolder, Heart-Valve, Prosthesis
- LWSImplantable Cardioverter Defibrillator (Non-Crt)
- DXYImplantable Pacemaker Pulse-Generator
- LWPImplantable Pulse Generator, Pacemaker (Non-Crt)
- DWSInstruments, Surgical, Cardiovascular
- DTGMagnet, Test, Pacemaker
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- DTZOxygenator, Cardiopulmonary Bypass
- OSRPacemaker/Icd/Crt Non-Implanted Components
- NVZPulse Generator, Permanent, Implantable
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- DTNReservoir, Blood, Cardiopulmonary Bypass
- KRHRing, Annuloplasty
- DTISizer, Heart-Valve, Prosthesis
- DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2988-2020 | Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. | LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S/M. | Class II | Terminated | |
| Z-2987-2020 | Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. | LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S/M. | Class II | Terminated | |
| Z-2986-2020 | Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. | LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S/M. | Class II | Terminated | |
| Z-2985-2020 | Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI: 8022057015228 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. | LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S/M. | Class II | Terminated | |
| Z-2984-2020 | Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. | LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S/M. | Class II | Terminated | |
| Z-3233-2017 | Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take. | Class II | Terminated | |
| Z-3232-2017 | Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac ResynchronizationTherapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take. | Class II | Terminated | |
| Z-3231-2017 | Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take. | Class II | Terminated | |
| Z-3230-2017 | Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take. | Class II | Terminated | |
| Z-3229-2017 | Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take. | Class II | Terminated | |
| Z-3228-2017 | Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take. | Class II | Terminated | |
| Z-2114-2017 | INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). OVATIO CRT 6750, PARADYM CRT-D 8750, PARADYM SonR 8770, PARADYM RF CRT-D 9750, PARADYM RF SonR 9770 and INTENSIA CRT-D 174 are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The devices are also indicated for the reduction of heart failure symptoms in medically optimized NYHA Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer. | Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. | Class II | Terminated | |
| Z-2113-2017 | PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF SonR 9770 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). OVATIO CRT 6750, PARADYM CRT-D 8750, PARADYM SonR 8770, PARADYM RF CRT-D 9750, PARADYM RF SonR 9770 and INTENSIA CRT-D 174 are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The devices are also indicated for the reduction of heart failure symptoms in medically optimized NYHA Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer. | Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. | Class II | Terminated | |
| Z-2112-2017 | OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). OVATIO CRT 6750, PARADYM CRT-D 8750, PARADYM SonR 8770, PARADYM RF CRT-D 9750, PARADYM RF SonR 9770 and INTENSIA CRT-D 174 are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The devices are also indicated for the reduction of heart failure symptoms in medically optimized NYHA Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer. | Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. | Class II | Terminated | |
| Z-0805-2014 | ORCHESTRA/ORCHESTRA PLUS Programmer | Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a follow-up exam of patients implanted with a REPLY or ESPRIT pacemaker. | Class II | Terminated |
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