FDA Device recall Z-1276-2023
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-…
- FDA Device
- Class II
- ongoing
- Published 2023-03-29
On 2023-03-29 the FDA classified a Class II recall of 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-… by Datascope, citing there is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1276-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-28 |
| Published | 2023-03-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Datascope |
| Distribution | n/a |
Product
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, and 0998-00-0800-65
Reason
There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.
Identifiers
| code_info | Model Number: 0998-00-0800-31, UDI-DI: 10607567109053; Model Number: 0998-00-0800-32, UDI-DI: 10607567111117; Model Num…Model Number: 0998-00-0800-31, UDI-DI: 10607567109053; Model Number: 0998-00-0800-32, UDI-DI: 10607567111117; Model Number: 0998-00-0800-33, UDI-DI: 10607567109008; Model Number: 0998-00-0800-35, UDI-DI: 10607567109107; Model Number: 0998-00-0800-45, UDI-DI: 10607567108421; Model Number: 0998-00-0800-52, UDI-DI: 10607567108438; Model Number: 0998-00-0800-53, UDI-DI: 10607567108391; Model Number: 0998-00-0800-55, UDI-DI: 10607567108414; Model Number: 0998-00-0800-65, UDI-DI: 10607567113432; Serial Numbers: CB355244F2, CB355245F2, CB356759G2, CB356760G2, CB351303D2 CB355431F2 CB355432F2 CB355433F2 CB355434F2 CB355435F2 CB356761G2 CB356762G2 CB356763G2 CB356764G2 CB356765G2 CB351313D2 CB352952E2 CB352953E2 CB355240F2 CB355241F2 CB355242F2 CB355243F2 CB356766G2 CB356767G2 CB356768G2 CB356769G2 CB356770G2 CH351787D2 CH352224D2 CH352225D2 CH352228D2 CH352280E2 CH352283E2 CH352284E2 CH352287E2 CH352289E2 CH352290E2 CH352297E2 CH352298E2 CH353439E2 CH353443E2 CH353445E2 CH353448E2 CH353451E2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1276-2023%22
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