510(k) K112372 ยท DSP System, Balloon, Intra-Aortic And Control
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
| Applicant | Cardiac Assist, Maquet Cardiovascular, LLC, Manwah NJ, US |
| Decision | Substantially Equivalent, Sep 15, 2011 |
| Received | Aug 17, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112372
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2026 | Datascope Corp. Battery Charging Station;
Model: 0998-00-0802; Open, Classified |
DSP | None listed |
| Dec 16, 2025 | Datascope Corp. Cardiosave Hybrid Open, Classified |
DSP | None listed |
| Dec 16, 2025 | Datascope Corp. Cardiosave Rescue Open, Classified |
DSP | None listed |
| Dec 11, 2025 | Datascope Corp. Cardiosave Hybrid. Intra-Aortic Balloon Pump system. Open, Classified |
DSP | None listed |
| Jun 14, 2023 | Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX Open, Classified |
DSP | None listed |
| Apr 26, 2023 | Datascope Corp. MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32 Open, Classified |
DSP | None listed |
| Mar 22, 2023 | Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55 Open, Classified |
DSP | None listed |
| Mar 22, 2023 | Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 Open, Classified |
DSP | None listed |
| Mar 22, 2023 | Datascope Corp. Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140 Open, Classified |
DSP | None listed |
| Mar 22, 2023 | Datascope Corp. Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178 Open, Classified |
DSP | None listed |
| Mar 9, 2023 | Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0 Open, Classified |
DSP | None listed |
| Mar 9, 2023 | Datascope Corp. Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 Open, Classified |
DSP | None listed |
| Mar 6, 2023 | Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53 Open, Classified |
DSP | None listed |
| Mar 6, 2023 | Datascope Corp. Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85 Open, Classified |
DSP | None listed |
| Dec 30, 2021 | Datascope Corp. Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-UC-0800-34, 0998- Open, Classified |
DSP | None listed |
| Dec 30, 2021 | Datascope Corp. Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85. Open, Classified |
DSP | None listed |
| Oct 20, 2021 | Datascope Corp. Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers.
1. Cardiosave Hybrid. Model Numbers: 0998-00- Open, Classified |
DSP | None listed |
| Oct 7, 2021 | Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0 Open, Classified |
DSP | None listed |
| Sep 8, 2021 | Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0 Open, Classified |
DSP | None listed |
| Apr 28, 2021 | Datascope Corp. Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998 Open, Classified |
DSP | None listed |
| Apr 28, 2021 | Datascope Corp. Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998 Open, Classified |
DSP | None listed |
| Jul 16, 2019 | Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53
For cardiovascular use. Open, Classified |
DSP | None listed |
| Jul 16, 2019 | Datascope Corp. Cardiosave Rescue IABP, 0998-00-0800-83
Intra-Aortic Balloon Pump
For cardiovascular use. Open, Classified |
DSP | None listed |
| Jul 16, 2019 | Datascope Corp. CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53
For cardiovascular use. Open, Classified |
DSP | None listed |
| Jul 16, 2019 | Datascope Corp. CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55
For cardiovascular use. Open, Classified |
DSP | None listed |
| May 3, 2018 | Maquet Datascope Corp - Cardiac Assist Division CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179 Open, Classified |
DSP | None listed |
| Dec 23, 2016 | Maquet Datascope Corp - Cardiac Assist Division CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX
Li-Ion Battery affected part number is 0146-00-0097
Product Usage:
The CARDIOSAVE Hybrid Intra-Aortic Ball Terminated |
DSP | None listed |
| Dec 16, 2015 | Maquet Datascope Corp - Cardiac Assist Division Cardiosave Hybrid and rescue IABP Terminated |
DSP | None listed |
| Feb 23, 2015 | Maquet Datascope Corp - Cardiac Assist Division Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) Terminated |
DSP | None listed |
| Feb 7, 2015 | Maquet Datascope Corp - Cardiac Assist Division CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998 Terminated |
DSP | None listed |
| Jan 9, 2013 | Maquet Cardiovascular, LLC CARDIOSAVE Intra-Aortic Balloon Pump
An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpuls Terminated |
DSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.