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Datascope Corp.

76 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Battery Charging Station; Model: 0998-00-0802; recall (Z-1587-2026)Datascope Corp.2026-03-19
CS100 IABP. Software Version CS100 IABP Q.01. recall (Z-1486-2026)Datascope Corp.2026-03-03
CS300 IABP. Software Version CS300 IABP C.01. recall (Z-1487-2026)Datascope Corp.2026-03-03
Cardiosave Hybrid recall (Z-0931-2026)Datascope Corp.2025-12-16
Cardiosave Rescue recall (Z-0932-2026)Datascope Corp.2025-12-16
Cardiosave Hybrid. Intra-Aortic Balloon Pump system. recall (Z-0916-2026)Datascope Corp.2025-12-11
Cardiosave Rescue. Intra-Aortic Balloon Pump system. recall (Z-0917-2026)Datascope Corp.2025-12-11
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01 recall (Z-0311-2025)Datascope Corp.2024-11-05
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to infla recall (Z-3134-2024)Datascope Corp.2024-09-20
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to infla recall (Z-3135-2024)Datascope Corp.2024-09-20
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to infla recall (Z-3136-2024)Datascope Corp.2024-09-20
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to infla recall (Z-3137-2024)Datascope Corp.2024-09-20
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC recall (Z-2486-2023)Datascope Corp.2023-08-31
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00 recall (Z-2487-2023)Datascope Corp.2023-08-31
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC recall (Z-2431-2023)Datascope Corp.2023-08-30
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00 recall (Z-2432-2023)Datascope Corp.2023-08-30
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC recall (Z-2433-2023)Datascope Corp.2023-08-30
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00 recall (Z-2434-2023)Datascope Corp.2023-08-30
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC recall (Z-2435-2023)Datascope Corp.2023-08-30
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00 recall (Z-2436-2023)Datascope Corp.2023-08-30
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC recall (Z-2437-2023)Datascope Corp.2023-08-30
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00 recall (Z-2438-2023)Datascope Corp.2023-08-30
YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pul recall (Z-2216-2023)Datascope Corp.2023-07-21
SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counte recall (Z-2217-2023)Datascope Corp.2023-07-21
TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter puls recall (Z-2218-2023)Datascope Corp.2023-07-21
MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pu recall (Z-2219-2023)Datascope Corp.2023-07-21
MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter puls recall (Z-2220-2023)Datascope Corp.2023-07-21
SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide c recall (Z-2221-2023)Datascope Corp.2023-07-21
SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide co recall (Z-2222-2023)Datascope Corp.2023-07-21
LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter p recall (Z-2223-2023)Datascope Corp.2023-07-21
REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide recall (Z-2224-2023)Datascope Corp.2023-07-21
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00- recall (Z-2151-2023)Datascope Corp.2023-07-20
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00- recall (Z-2152-2023)Datascope Corp.2023-07-20
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00- recall (Z-2149-2023)Datascope Corp.2023-07-19
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00- recall (Z-2150-2023)Datascope Corp.2023-07-19
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Nu recall (Z-1907-2023)Datascope Corp.2023-06-14
MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32 recall (Z-1462-2023)Datascope Corp.2023-04-26
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00 recall (Z-1276-2023)Datascope Corp.2023-03-22
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-08 recall (Z-1277-2023)Datascope Corp.2023-03-22
Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140 recall (Z-1278-2023)Datascope Corp.2023-03-22
Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Numbe recall (Z-1279-2023)Datascope Corp.2023-03-22
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part nu recall (Z-1145-2023)Datascope Corp.2023-03-09
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part nu recall (Z-1146-2023)Datascope Corp.2023-03-09
Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800- recall (Z-1147-2023)Datascope Corp.2023-03-09
Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85 recall (Z-1148-2023)Datascope Corp.2023-03-09
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00 recall (Z-1229-2023)Datascope Corp.2023-03-06
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00 recall (Z-1230-2023)Datascope Corp.2023-03-06
Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800- recall (Z-1231-2023)Datascope Corp.2023-03-06
Cardiosave Rescue. Model Number: 0998-00-0800-83. recall (Z-1232-2023)Datascope Corp.2023-03-06
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00 recall (Z-0885-2023)Datascope Corp.2023-01-19
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00 recall (Z-0886-2023)Datascope Corp.2023-01-19
Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-3 recall (Z-0336-2022)Datascope Corp.2021-12-30
Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-7 recall (Z-0337-2022)Datascope Corp.2021-12-30
Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid recall (Z-0091-2022)Datascope Corp.2021-10-20
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-08 recall (Z-0075-2022)Datascope Corp.2021-10-07
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-08 recall (Z-0076-2022)Datascope Corp.2021-10-07
Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. recall (Z-1506-2021)Datascope Corp.2021-04-28
Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. recall (Z-1507-2021)Datascope Corp.2021-04-28
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use recall (Z-1939-2019)Datascope Corp.2019-07-16
Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use. recall (Z-1940-2019)Datascope Corp.2019-07-16
CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use. recall (Z-1941-2019)Datascope Corp.2019-07-16
CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use. recall (Z-1942-2019)Datascope Corp.2019-07-16
CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use. recall (Z-1943-2019)Datascope Corp.2019-07-16
CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use. recall (Z-1944-2019)Datascope Corp.2019-07-16
Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump, recall (Z-0567-2008)Datascope Corp2008-01-31
Anestar and Anestar Plus Anesthesia System. recall (Z-0929-06)Datascope Corp2006-06-02
Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor. recall (Z-0437-06)Datascope Corp2006-01-24
Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs. Moni recall (Z-0176-06)Datascope Corp2005-11-23
Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physio recall (Z-0177-06)Datascope Corp2005-11-23
Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor. recall (Z-1567-05)Datascope Corp2005-09-21
Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor. recall (Z-1104-05)Datascope Corp2005-08-06
Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm). recall (Z-0018-05)Datascope Corp2004-10-13
Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm). recall (Z-1483-04)Datascope Corp2004-09-21
Anestar Anesthesia Delivery System recall (Z-1441-04)Datascope Corp2004-09-09
Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system. recall (Z-1050-04)Datascope Corp2004-07-20
10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datas recall (Z-0916-03)Datascope Corp2003-06-05

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Every clearance here is in the API, with alerts when new ones post.