FDA Device recall Z-0336-2022
Cardiosave Hybrid IntraAortic Balloon Pump
- FDA Device
- Class I
- ongoing
- Published 2021-12-22
On 2021-12-22 the FDA classified a Class I recall of Cardiosave Hybrid IntraAortic Balloon Pump by Datascope, citing firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0336-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-11-15 |
| Published | 2021-12-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Datascope |
| Distribution | US |
Product
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, 0998-00-0800-35, 0998-UC-0800-35, 0998-00-0800-36, 0998-UC-0800-36, 0998-00-0800-45, 0998-UC-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65, 0998-UC-0800-65.
Reason
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
Identifiers
| code_info | All Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-31, 106075671…All Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-31, 10607567109053; 0998-UC-0800-31, 10607567109053; 0998-00-0800-32, 10607567111117; 0998-UC-0800-32, 10607567111117; 0998-00-0800-33, 10607567109008; 0998-UC-0800-33, 10607567109008; 0998-00-0800-34, 10607567111940; 0998-UC-0800-34, 10607567111940; 0998-00-0800-35, 10607567109107; 0998-UC-0800-35, 10607567109107; 0998-00-0800-36, 10607567114187; 0998-UC-0800-36, 10607567114187; 0998-00-0800-45, 10607567108421; 0998-UC-0800-45, 10607567108421; 0998-00-0800-52, 10607567108438; 0998-UC-0800-52, 10607567108438; 0998-00-0800-53, 10607567108391; 0998-UC-0800-53, 10607567108391; 0998-00-0800-55, 10607567108414; 0998-UC-0800-55, 10607567108414; 0998-00-0800-65, 10607567113432; 0998-UC-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-0336-2022%22
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