FDA Device recall Z-2151-2023
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0…
- FDA Device
- Class I
- ongoing
- Published 2023-07-26
On 2023-07-26 the FDA classified a Class I recall of Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0… by Datascope, citing an unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected inter….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2151-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-06-05 |
| Published | 2023-07-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Datascope |
| Distribution | US |
Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998-00-0800-55* *Not US distribution
Reason
An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.
Identifiers
| code_info | All Unit Serial Numbers Model UDI 0998-00-0800-31 10607567109053 0998-00-0800-32 10607567111117 099…All Unit Serial Numbers Model UDI 0998-00-0800-31 10607567109053 0998-00-0800-32 10607567111117 0998-00-0800-33 10607567109008 0998-00-0800-34 10607567111940 0998-00-0800-35 10607567109107 0998-00-0800-45 10607567108421 0998-00-0800-52 10607567108438 0998-00-0800-53 10607567108391 0998-00-0800-55 10607567108414 0998-00-0800-65 10607567113432 |
|---|
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-2151-2023%22
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