FDA Device recall Z-1062-2015
CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump
- FDA Device
- Class II
- terminated
- Published 2015-02-18
On 2015-02-18 the FDA classified a Class II recall of CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump by Maquet Datascope Cardiac Assist Division, citing ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IAB….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1062-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-16 |
| Published | 2015-02-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Maquet Datascope Cardiac Assist Division |
| Distribution | n/a |
Product
CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system used to inflate and deflate intra-aortic balloons.
Reason
Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit and may become dislodged and remain in IABPs fiber-optic receptacle.
Identifiers
| code_info | Sensation 7 fr.34 cc IAB Demonstration Unit 0684-DC-0433 0684-DO-0433 0684-DC-0469 0684-DO-0469 Sensation 7 Fr…Sensation 7 fr.34 cc IAB Demonstration Unit 0684-DC-0433 0684-DO-0433 0684-DC-0469 0684-DO-0469 Sensation 7 Fr. 40 cc IAB Demonstration Unit 0684-DC-0434 0684-DO-0434 0684-DC-0470 0684-DO-0470 Sesnsation Plus 7.5 Fr. 40cc IAB Demonstration Units 0684-DC-0567 0684-DO-0567 0684-DC-0568 0684-DO-0568 Sensation Plus 7.5 Fr. 50cc IAB Demonstration Units 0684-DC-0575 0684-DO-0575 0684-DC-0576 0684-DO-0576 Sensation Plus 8 Fr. 50 cc IAB Demonstration Unit 0684-DC-0272 0684-DO-0272 |
|---|
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-1062-2015%22
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