Datascope Corp.
Mahwah, NJ, US
Datascope Corp. appears in FDA device records in Mahwah, NJ. FDA records list 139 510(k) clearances between and , 13 PMA records and 4 registered establishments. As of , FDA records show 226 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
4 namesFDA records resolved to Datascope Corp. 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.
- Maquet Datascope Corp - Cardiac Assist Divisionenforcement report, recall
- MINDRAY DS USA, Inc.registration, 510(k)
- Mindray DS USA, Inc. dba Mindray North Americaenforcement report, recall
- Mindray DS USA, Inc., dba Datascope Patient Monitoringrecall
510(k) clearance history
Showing 50 of 139FDA records hold 139 510(k) clearances for Datascope Corp. between 1976 and 2019. The busiest year on record is 1990, with 16. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 4 |
| 1978 | 3 |
| 1979 | 1 |
| 1981 | 8 |
| 1982 | 5 |
| 1983 | 5 |
| 1984 | 1 |
| 1985 | 7 |
| 1986 | 2 |
| 1987 | 5 |
| 1988 | 6 |
| 1989 | 5 |
| 1990 | 16 |
| 1991 | 7 |
| 1992 | 3 |
| 1993 | 10 |
| 1994 | 3 |
| 1995 | 2 |
| 1996 | 2 |
| 1997 | 4 |
| 1998 | 4 |
| 1999 | 1 |
| 2000 | 6 |
| 2001 | 1 |
| 2002 | 3 |
| 2003 | 4 |
| 2004 | 4 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 4 |
| 2010 | 1 |
| 2011 | 1 |
| 2013 | 2 |
| 2015 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K190884 | TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool | GDW | Substantially Equivalent | |
| K181122 | CARDIOSAVE Intra-Aortic Balloon Pump | DSP | Substantially Equivalent | |
| K172305 | CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump | DSP | Substantially Equivalent | |
| K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case | DSP | Substantially Equivalent | |
| K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump | DSP | Substantially Equivalent | |
| K132026 | V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21 | MHX | Substantially Equivalent | |
| K133074 | MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES | DSP | Substantially Equivalent | |
| K102471 | AS3700 ANESTHSIA DELIVERY SYSTEM | BSZ | Substantially Equivalent | |
| K102004 | ENDEAVOUR MONITORING SYSTEM | MHX | Substantially Equivalent | |
| K071805 | NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX | DSI | Substantially Equivalent | |
| K062569 | SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING | DXC | Substantially Equivalent | |
| K062098 | SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX | MHX | Substantially Equivalent | |
| K063525 | DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM | DSP | Substantially Equivalent | |
| K062754 | GAS MODULE SE, MODEL 0998-00-0481-02 | BZK | Substantially Equivalent | |
| K051897 | TRIO MONITOR | MWI | Substantially Equivalent | |
| K042016 | DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER | MSD | Substantially Equivalent | |
| K041907 | TRIO MONITOR | MWI | Substantially Equivalent | |
| K041281 | DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES | DSP | Substantially Equivalent | |
| K032338 | TRIO MONITOR MODEL 0998-00-0600 | MWI | Substantially Equivalent | |
| K031760 | VIEWPOINT TELEMETRY SYSTEM | MHX | Substantially Equivalent | |
| K031849 | SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX | MHX | Substantially Equivalent | |
| K031636 | CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX | DSP | Substantially Equivalent | |
| K031569 | DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX | DSP | Substantially Equivalent | |
| K020550 | PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX | DSI | Substantially Equivalent | |
| K020257 | DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S | DSP | Substantially Equivalent | |
| K011540 | VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07 | MHX | Substantially Equivalent | |
| K013326 | MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B | DSP | Substantially Equivalent | |
| K003598 | DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320 | DSP | Substantially Equivalent | |
| K002949 | MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC | DSP | Substantially Equivalent | |
| K002365 | DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET | DYB | Substantially Equivalent | |
| K001198 | DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET | DQX | Substantially Equivalent | |
| K994157 | DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329 | DSP | Substantially Equivalent | |
| K993531 | PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX | DSI | Substantially Equivalent | |
| K983575 | ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX | DXN | Substantially Equivalent | |
| K974178 | PASSPORT 5L-CE MODEL 0998-00-0131XXX | DRT | Substantially Equivalent | |
| K980780 | DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES | DSP | Substantially Equivalent | |
| K980385 | DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES | DSP | Substantially Equivalent | |
| K974903 | GAS MODULE II, MODEL 0998-00-0143 | CBS | Substantially Equivalent | |
| K973007 | DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER | DYB | Substantially Equivalent | |
| K970061 | ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX) | DQA | Substantially Equivalent | |
| K965236 | SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP) | DSP | Substantially Equivalent | |
| K964987 | DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0 | DSP | Substantially Equivalent | |
| K961509 | INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED | DSP | Substantially Equivalent | |
| K960166 | PERCOR STAT-DL 9.5 FR. 34 & 40CC | DSP | Substantially Equivalent | |
| K943896 | GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS | DQX | Substantially Equivalent | |
| K942454 | DATASCOPE 95 AND 97 IAB PUMP CONSOLE | DSP | Substantially Equivalent | |
| K944460 | DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD | DSP | Substantially Equivalent | |
| K940231 | INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION | DSP | Substantially Equivalent | |
| K940178 | PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION | DSP | Substantially Equivalent | |
| K926451 | DATASCOPE MULTINEX II | CBQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007965489 | 3007965489 | Datascope Corp | 45 Barbour Pond Drive, Wayne, NJ 07470 US | 2026 | |
| 2248146 | 1000222374 | Datascope Corp. | 15 Law Dr, FAIRFIELD, NJ 07004 US | 2026 | |
| 2249723 | 3001418283 | Datascope Corp. | 1300 Macarthur Blvd, MAHWAH, NJ 07430 US | 2026 | |
| 2221819 | 2221819 | MINDRAY DS USA, Inc. | 800 MACARTHUR BLVD., Mahwah, NJ 07430 US | 2026 | and 50 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DSJAlarm, Blood-Pressure
- DRRAmplifier And Signal Conditioner, Biopotential
- DRQAmplifier And Signal Conditioner, Transducer Signal
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- CCIAnalyzer, Gas, Nitrogen, Gaseous-Phase
- CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- KRXCalibrator For Cell Indices
- KRZCalibrator For Hemoglobin And Hematocrit Measurement
- KRYCalibrator For Platelet Counting
- KSACalibrator For Red-Cell And White-Cell Counting
- DQRCannula, Catheter
- DQOCatheter, Intravascular, Diagnostic
- DQYCatheter, Percutaneous
- DXCClamp, Vascular
- DSKComputer, Blood-Pressure
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- FLLContinuous Measurement Thermometer
- GKZCounter, Differential Cell
- DSIDetector And Alarm, Arrhythmia
- JCBDetergent
- KMKDevice, Intravascular Catheter Securement
- DREDilator, Vessel, For Percutaneous Catheterization
- GIFDiluent, Blood Cell
- GXYElectrode, Cutaneous
- DRXElectrode, Electrocardiograph
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CGZElectrode, Ion-Specific, Chloride
- BSZGas-Machine, Anesthesia
- CFRHexokinase, Glucose
- DYBIntroducer, Catheter
- JPKMixture, Hematology Quality Control
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- DQAOximeter
- DSBPlethysmograph, Impedance
- DPTProbe, Blood-Flow, Extravascular
- GGKProducts, Red-Cell Lysing Products
- DSFRecorder, Paper Chart
- KDPRegulator, Vacuum
- BZKSpirometer, Monitoring (W/Wo Alarm)
- GDWStaple, Implantable
- KOIStimulator, Nerve, Peripheral, Electric
- DSPSystem, Balloon, Intra-Aortic And Control
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- FQOTable, Operating-Room, Ac-Powered
- JEATable, Surgical With Orthopedic Accessories, Ac-Powered
- KRCTester, Electrode, Surface, Electrocardiographic
- DRSTransducer, Blood-Pressure, Extravascular
- ITXTransducer, Ultrasonic, Diagnostic
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
- CADVaporizer, Anesthesia, Non-Heated
- CBKVentilator, Continuous, Facility Use
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 226| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1587-2026 | Battery Charging Station; Model: 0998-00-0802; | The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue. | Class III | Open, Classified | |
| Z-1487-2026 | CS300 IABP. Software Version CS300 IABP C.01. | The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated. | Class II | Open, Classified | |
| Z-1486-2026 | CS100 IABP. Software Version CS100 IABP Q.01. | The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated. | Class II | Open, Classified | |
| Z-0920-2026 | Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1 HP Pro Mini 400 G9 Desktop PC with Realtek HD Audio Driver Officially Released by HP (audio driver version 6.0.9484.1) | When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing. | Class II | Open, Classified | |
| Z-0917-2026 | Cardiosave Rescue. Intra-Aortic Balloon Pump system. | The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. | Class II | Open, Classified | |
| Z-0916-2026 | Cardiosave Hybrid. Intra-Aortic Balloon Pump system. | The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. | Class II | Open, Classified | |
| Z-0932-2026 | Cardiosave Rescue | The IFU addendum updates the Vibration and Shock Table to reference the correct standards. | Class III | Open, Classified | |
| Z-0931-2026 | Cardiosave Hybrid | The IFU addendum updates the Vibration and Shock Table to reference the correct standards. | Class III | Open, Classified | |
| Z-0721-2026 | Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Safety Filling adapter), Part Number E115-066758-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery. | Potential for anesthesia leakage. | Class II | Open, Classified | |
| Z-0720-2026 | Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery. | Potential for anesthesia leakage. | Class II | Open, Classified | |
| Z-2622-2025 | BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021, Q6660E-PA00012, 6660E-PA00030, 6660E-PA00041, 6660E-PA00035, 6660E-PA00032, 6660E-PA00031. Software Versions: 1.04.00.01, 01.05.00.01, 01.06.00.01, and 01.06.01.01 The patient monitor is intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters. | Potential for activation of an abnormal alarm pause. | Class II | Open, Classified | |
| Z-0311-2025 | MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01 | There is discrepant labeling on the inner and outer packaging of the device. | Class II | Open, Classified | |
| Z-3137-2024 | CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. | Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices. | Class I | Open, Classified | |
| Z-3136-2024 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. | Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices. | Class I | Open, Classified | |
| Z-3135-2024 | CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. | Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices. | Class I | Open, Classified | |
| Z-3134-2024 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. | Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices. | Class I | Open, Classified | |
| Z-2952-2024 | Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number115-066759-00 | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention | Class II | Open, Classified | |
| Z-2951-2024 | Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number 115-066758-00 | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention | Class II | Open, Classified | |
| Z-2950-2024 | Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: 115-066756-00 | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention | Class II | Open, Classified | |
| Z-2949-2024 | Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number 115-066755-00 | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention | Class II | Open, Classified | |
| Z-2432-2023 | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 | Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge. | Class I | Open, Classified | |
| Z-2431-2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65 | Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge. | Class I | Open, Classified | |
| Z-2434-2023 | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85, | Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode. | Class I | Open, Classified | |
| Z-2433-2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65, 0998-00-0800-36, 0998-UC-0800-32, 0998-UC-0800-34, 0998-UC-0800-35, 0998-UC-0800-36, 0998-UC-0800-45, 0998-UC-0800-65, | Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode. | Class I | Open, Classified | |
| Z-2436-2023 | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 | Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IFU: Patient Movement (coughing, general movement, and swallowing). Blood in the circuit, kinks/abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms. The firm's HHE also identified hardware issues related to these alarms. | Class I | Open, Classified |
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