FDA Device recall Z-1248-2016
Cardiosave Hybrid and rescue IABP
- FDA Device
- Class II
- terminated
- Published 2016-04-06
On 2016-04-06 the FDA classified a Class II recall of Cardiosave Hybrid and rescue IABP by Maquet Datascope Cardiac Assist Division, citing maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1248-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-16 |
| Published | 2016-04-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Maquet Datascope Cardiac Assist Division |
| Distribution | US |
Product
Cardiosave Hybrid and rescue IABP
Reason
Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.
Identifiers
| code_info | Cardiosave Hybrid IABP 0998-00-0800-53,0998-UC-0800-53, Cardiosave Rescue IABP 0998-00-0800-83 & 0998-UC-0800-83 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1248-2016%22
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