FDA Device recall Z-0886-2023
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-…
- FDA Device
- Class I
- ongoing
- Published 2023-01-25
On 2023-01-25 the FDA classified a Class I recall of Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-… by Datascope, citing the Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0886-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-12-19 |
| Published | 2023-01-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Datascope |
| Distribution | US |
Product
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model 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.
Reason
The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.
Identifiers
| code_info | All Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-75, 106075…All Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-75, 10607567112312; 0998-00-0800-83, 10607567108407; 0998-00-0800-85, 10607567113449; 0998-UC-0800-75, 10607567112312; 0998-UC-0800-83, 10607567108407; 0998-UC-0800-85, 10607567113449. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Datascope
- Battery Charging Station
FDA Device · Class III · 2026-03-25 · Datascope - CS300 IABP. Software Version CS300 IABP C.01
FDA Device · Class II · 2026-03-11 · Datascope - CS100 IABP. Software Version CS100 IABP Q.01
FDA Device · Class II · 2026-03-11 · Datascope - Cardiosave Rescue
FDA Device · Class III · 2025-12-24 · Datascope - Cardiosave Hybrid
FDA Device · Class III · 2025-12-24 · Datascope
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0886-2023%22
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