FDA Device recall Z-1140-2015
Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
- FDA Device
- Class II
- terminated
- Published 2015-03-04
On 2015-03-04 the FDA classified a Class II recall of Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) by Maquet Datascope Cardiac Assist Division, citing power supply malfunction complaints related to suboptimal thermal management.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1140-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-30 |
| Published | 2015-03-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Maquet Datascope Cardiac Assist Division |
| Distribution | US |
Product
Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
Reason
Power supply malfunction complaints related to suboptimal thermal management.
Identifiers
| code_info | 0998-00-0800-31 0998-UC-0800-31 0998-00-0800-32 0998-UC-0800-33 0998-00-0800-33 0998-UC-0800-52 0998-00-0800-34 0998…0998-00-0800-31 0998-UC-0800-31 0998-00-0800-32 0998-UC-0800-33 0998-00-0800-33 0998-UC-0800-52 0998-00-0800-34 0998-UC-0800-53 0998-00-0800-35 0998-UC-0800-55 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55. CARDIOSAVE Hybrid IABPs serviced with a new/replacement power supply after August 19, 2014 are not affected. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1140-2015%22
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