Datascope Corp.
Datascope Corp. holds FDA 510(k) medical device clearances, first cleared 1976, most recent 2019, with 67 FDA device recalls on record.
Top product codes for Datascope Corp.
FDA recalls by Datascope Corp.
10 most recent of 67- Z-1587-2026 — Battery Charging Station; Model: 0998-00-0802;
- Z-1487-2026 — CS300 IABP. Software Version CS300 IABP C.01.
- Z-1486-2026 — CS100 IABP. Software Version CS100 IABP Q.01.
- Z-0917-2026 — Cardiosave Rescue. Intra-Aortic Balloon Pump system.
- Z-0916-2026 — Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
- Z-0931-2026 — Cardiosave Hybrid
- Z-0932-2026 — Cardiosave Rescue
- Z-0311-2025 — MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
- Z-3134-2024 — CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
- Z-3136-2024 — CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Datascope Corp.
1–100 of 136- K190884 — TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool
- K181122 — CARDIOSAVE Intra-Aortic Balloon Pump
- K172305 — CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
- K163542 — CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
- K151254 — CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
- K133074 — MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES
- K071805 — NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX
- K062569 — SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING
- K062098 — SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX
- K063525 — DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM
- K062754 — GAS MODULE SE, MODEL 0998-00-0481-02
- K051897 — TRIO MONITOR
- K042016 — DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER
- K041907 — TRIO MONITOR
- K041281 — DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
- K032338 — TRIO MONITOR MODEL 0998-00-0600
- K031760 — VIEWPOINT TELEMETRY SYSTEM
- K031849 — SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX
- K031636 — CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
- K031569 — DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
- K020550 — PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
- K020257 — DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB
- K011540 — VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07
- K013326 — MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B
- K003598 — DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320
- K002949 — MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC
- K002365 — DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET
- K001198 — DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET
- K994157 — DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329
- K993531 — PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
- K983575 — ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX
- K974178 — PASSPORT 5L-CE MODEL 0998-00-0131XXX
- K980780 — DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES
- K980385 — DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES
- K974903 — GAS MODULE II, MODEL 0998-00-0143
- K973007 — DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER
- K970061 — ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)
- K965236 — SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)
- K964987 — DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0
- K961509 — INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED
- K960166 — PERCOR STAT-DL 9.5 FR. 34 & 40CC
- K943896 — GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS
- K942454 — DATASCOPE 95 AND 97 IAB PUMP CONSOLE
- K944460 — DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD
- K940231 — INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION
- K940178 — PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION
- K911000 — PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON
- K914802 — DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL
- K926451 — DATASCOPE MULTINEX II
- K926099 — DATASCOPE 6000 MONITOR
- K920427 — PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON
- K922103 — IAB ANCHOR
- K905663 — PEDIATRIC INTRA-AORTIC BALLOON CATHETERS
- K930303 — DATASCOPE MULTINEX ID PLUS
- K922235 — SYSTEM 97
- K921638 — SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE
- K921526 — DATASCOPE PASSPORT MONITOR WITH CO2
- K912629 — DATASCOPE SYSTEM 95
- K913847 — SYSTEM 90 AND SYSTEM 90T
- K910997 — DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON
- K911598 — DATASCOPE PASSPORT MONITOR
- K910116 — TURBO SUPPORT CATHETER
- K905056 — PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT
- K910106 — DATASCOPE MULTINEX ID MONITOR
- K905432 — DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
- K902674 — DATASCOPE ARTERIAL CANNULA W/ACCESS PORT
- K904476 — VESSEL DILATOR
- K904477 — GUIDEWIRE
- K903930 — DATASCOPE PERCOR STAT DL 10.5 FR 50CC
- K904414 — DATASCOPE PERCOR STAT DL 9.5 FR40CC STERIL ETO GAS
- K903769 — PERCOR STAT DL 9.5 FR 34CC INTRA-AORTIC BALLOON
- K903867 — DATASCOPE PERCOR STAT DL 10.5 FR 40CC
- K903892 — DATASCOPE PERCOR STAT 8.5 FR 40CC INTRA-AORTIC BAL
- K903893 — DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL
- K904018 — DATASCOPE PERCOR STAT DL 9.5 FR 40CC INTRA-AOR BAL
- K902932 — DATASCOPE PERCOR PERCUTANEOUS INTRODUCER W/PEELABL
- K903736 — DATASCOPE PERCOR STAT DL10.5 FR40CC IN AORTIC BAL
- K902057 — PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG
- K896497 — PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON
- K901391 — DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER
- K901347 — DATASCOPE SLIDEWIRE(TM)
- K896430 — PERCOR STAT-DL 9.5 FR & STAT-SL 8.5 FR INTRA-AORTI
- K894940 — DATASCOPE STEERING HANDLE
- K894318 — DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
- K890807 — GUIDE WIRE INTRODUCER
- K893243 — INTRA AORTIC BALLOON
- K890800 — ROTATING HEMOSTATIC VALVE
- K883579 — CORONARY GUIDE WIRE
- K883254 — MULTINEX MONITOR (MODIFICATION)
- K880301 — 3000 PHYSIOLOGICAL MONITOR
- K880289 — DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL
- K874138 — ACCUCOM 2
- K872024 — CO2/02 MONITOR MULTINEX
- K870664 — GUIDE WIRE
- K863608 — DATASCOPE BALLOON DILATATION CATHETER
- K863219 — SYSTEM 90 TRANSPORT
- K863855 — ACCUSAT
- K863308 — 2200I PHYSIOLOGICAL MONITOR
- K864167 — PERCLUDER(TM)-DL OCCLUDING BALLOON(HEPARIN COATED)
- K860164 — 2500 PRINTER
Data sourced from openFDA. This site is unofficial and independent of the FDA.