LivaNova USA, Inc.
Houston, TX, US
LivaNova USA, INC. appears in FDA device records in Houston, TX. FDA records list 49 510(k) clearances between and , 243 PMA records and 2 registered establishments. As of , FDA records show 227 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 LivaNova USA, 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.
- Cobe Cardiovascular, Inc.510(k), recall
- Cyberonics, Inc.510(k), enforcement report, recall
- Sorin Group USA, Inc.510(k), PMA, enforcement report, recall
510(k) clearance history
FDA records hold 49 510(k) clearances for LivaNova USA, Inc. between 1992 and 2026. The busiest year on record is 1998, with 7. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 3 |
| 1993 | 3 |
| 1994 | 1 |
| 1995 | 1 |
| 1997 | 6 |
| 1998 | 7 |
| 1999 | 5 |
| 2000 | 5 |
| 2001 | 5 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 2 |
| 2005 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2013 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250937 | Venous Return Cannulae | DWF | Substantially Equivalent | |
| K250283 | RAP Femoral Venous Cannulae | DWF | Substantially Equivalent | |
| K233702 | SMARxT Tubing and Connectors | DWE | Substantially Equivalent | |
| K122735 | SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2 | GAT | Substantially Equivalent | |
| K102983 | VASCUCLEAR PRECISION BIPOLAR | GEI | Substantially Equivalent | |
| K092364 | MODEL 220 PATIENT MAGNET | DTG | Substantially Equivalent | |
| K050111 | SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG | DTN | Substantially Equivalent | |
| K042473 | COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM | JQC | Substantially Equivalent | |
| K040184 | DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER | DTM | Substantially Equivalent | |
| K033641 | SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 | DTN | Substantially Equivalent | |
| K030462 | COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 | KFM | Substantially Equivalent | |
| K021830 | SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM | DTR | Substantially Equivalent | |
| K011835 | COBE REVOLUTION | KFM | Substantially Equivalent | |
| K013480 | COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR | DTZ | Substantially Equivalent | |
| K012763 | SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM | DRT | Substantially Equivalent | |
| K001509 | STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE | DWF | Substantially Equivalent | |
| K012898 | MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM | DTR | Substantially Equivalent | |
| K004046 | COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | DTP | Substantially Equivalent | |
| K002493 | DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER | DTM | Substantially Equivalent | |
| K002591 | COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | DTP | Substantially Equivalent | |
| K994209 | STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP | DWF | Substantially Equivalent | |
| K000255 | COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR | DTZ | Substantially Equivalent | |
| K994389 | COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED | DTN | Substantially Equivalent | |
| K993001 | COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED | DTN | Substantially Equivalent | |
| K991452 | COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR | DTZ | Substantially Equivalent | |
| K991986 | COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION | CAC | Substantially Equivalent | |
| K990239 | COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | DTN | Substantially Equivalent | |
| K984456 | COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | DTN | Substantially Equivalent | |
| K981613 | COBE SMARXT TUBING AND CONNECTORS | DWE | Substantially Equivalent | |
| K982406 | COBE VACUUM RELIEF CHECK VALVE | MJJ | Substantially Equivalent | |
| K982254 | COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD | DTM | Substantially Equivalent | |
| K980786 | COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800 | DTN | Substantially Equivalent | |
| K974812 | COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR | DTZ | Substantially Equivalent | |
| K974897 | COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET | CAC | Substantially Equivalent | |
| K974085 | COBE OXYGENATOR PRODUCTS | DTZ | Substantially Equivalent | |
| K963518 | COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR | DTZ | Substantially Equivalent | |
| K973627 | STANDARD VOLUME PROCESSING SET FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM | CAC | Substantially Equivalent | |
| K964043 | COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS | DTZ | Substantially Equivalent | |
| K971669 | COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR | DTN | Substantially Equivalent | |
| K960974 | COBE CENTURY PERFUSION PUMP | DWB | Substantially Equivalent | |
| K962689 | COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH MODIFIED PLASMA RECOVERY PROGRAM (PRP) | CAC | Substantially Equivalent | |
| K944267 | HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA | DTR | Substantially Equivalent | |
| K933960 | PLASMA RECOVERY PROGRAM FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM | CAC | Substantially Equivalent | |
| K933625 | BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM | CAC | Substantially Equivalent | |
| K926467 | COBE CMS-FS MEMBRANE OXYGENATOR | DTZ | Substantially Equivalent | |
| K921343 | COBE PATIENT MONITORING PRODUCTS | DRS | Substantially Equivalent | |
| K922484 | COBE SAMPLING SITE | DQO | Substantially Equivalent | |
| K920312 | NEW COBE CARDIOPLEGIA SYSTEM | DTN | Substantially Equivalent | |
| K913773 | COBE BRAT SYSTEMS WITHOUT REINFUSION PROTECTION | CAC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1718850 | 1718850 | LivaNova USA, INC. | 14401 WEST 65TH WAY, ARVADA, CO 80004 US | 2026 | and 8 more, listed in full below |
| 1644487 | 1000117004 | LivaNova USA, Inc. | 100 CYBERONICS BLVD., HOUSTON, TX 77058 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KRIAccessory Equipment, Cardiopulmonary Bypass
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- CACApparatus, Autotransfusion
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DQOCatheter, Intravascular, Diagnostic
- GBSCatheter, Ventricular, General & Plastic Surgery
- JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- FLLContinuous Measurement Thermometer
- MJJCpb Check Valve, Retrograde Flow, In-Line
- DTPDefoamer, Cardiopulmonary Bypass
- DREDilator, Vessel, For Percutaneous Catheterization
- DWPDilator, Vessel, Surgical
- PZSDual Lumen Ecmo Cannula
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- HAOInstrument, Surgical, Non-Powered
- GCJLaparoscope, General & Plastic Surgery
- LOILaser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
- FQHLavage, Jet
- DTGMagnet, Test, Pacemaker
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- DTZOxygenator, Cardiopulmonary Bypass
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- DWBPump, Blood, Cardiopulmonary Bypass, Roller Type
- DTNReservoir, Blood, Cardiopulmonary Bypass
- GAESnare, Surgical
- MUZStimulator, Autonomic Nerve, Implanted (Depression)
- LYJStimulator, Autonomic Nerve, Implanted For Epilepsy
- MNQStimulator, Hypoglossal Nerve, Implanted, Apnea
- DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- DRSTransducer, Blood-Pressure, Extravascular
- DWETubing, Pump, Cardiopulmonary Bypass
Recall records
Showing 25 of 227| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1068-2025 | Brand Name: SenTiva DUO" Product Name: VNS Therapy SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000-D Generator was commercially approved for distribution in the U.S. on May 13, 2020 via PMA P970003/S231. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS). | Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue. | Class II | Open, Classified | |
| Z-1067-2025 | Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS). | Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue. | Class II | Open, Classified | |
| Z-1073-2025 | SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS). | Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device. | Class II | Open, Classified | |
| Z-1072-2025 | SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS). | Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device. | Class II | Open, Classified | |
| Z-0532-2022 | Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter) | A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less than the design specification. If the tubing becomes completely breached, the patient may experience discomfort or pain due to delivery of stimulation to an unintended location. If the inner lead conductor is exposed to body fluids the lead may break causing loss of therapy. | Class II | Terminated | |
| Z-0535-2021 | VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode. | During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated. | Class II | Terminated | |
| Z-0462-2021 | VNS Therapy AspireSR Generator | Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4. | Class II | Terminated | |
| Z-2464-2020 | Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period. | Class II | Terminated | |
| Z-2463-2020 | Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period. | Class II | Terminated | |
| Z-2462-2020 | 1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period. | Class II | Terminated | |
| Z-2461-2020 | 1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period. | Class II | Terminated | |
| Z-2460-2020 | 3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period. | Class II | Terminated | |
| Z-2459-2020 | 3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285 | XXX | Class II | Terminated | |
| Z-2458-2020 | 1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period. | Class II | Terminated | |
| Z-2457-2020 | Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period. | Class II | Terminated | |
| Z-2456-2020 | Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period. | Class II | Terminated | |
| Z-2455-2020 | Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period. | Class II | Terminated | |
| Z-2454-2020 | Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period. | Class II | Terminated | |
| Z-2453-2020 | Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period. | Class II | Terminated | |
| Z-2452-2020 | Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period. | Class II | Terminated | |
| Z-2451-2020 | Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period. | Class II | Terminated | |
| Z-2450-2020 | Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period. | Class II | Terminated | |
| Z-2449-2020 | Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00803622123238 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period. | Class II | Terminated | |
| Z-2448-2020 | Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period. | Class II | Terminated | |
| Z-2447-2020 | Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain