FDA Device recall Z-1523-2014
Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump
- FDA Device
- Class I
- terminated
- Published 2014-05-28
On 2014-05-28 the FDA classified a Class I recall of Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump by Maquet Datascope Cardiac Assist Division, citing potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut d….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1523-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-03-21 |
| Published | 2014-05-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Maquet Datascope Cardiac Assist Division |
| Distribution | US |
Product
Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.
Reason
Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.
Identifiers
| code_info | IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System 98XT 0998-00-0479-xx 0998-UC-0479-xx CS100i 0998…IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System 98XT 0998-00-0479-xx 0998-UC-0479-xx CS100i 0998-UC-0446Hxx 0998-UC-0479Hxx CS100 0998-00-3013-xx 0998-UC-3013-xx CS300 0998-00-3023-xx 0998-UC-3023-xx |
|---|
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-1523-2014%22
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