FDA Device recall Z-2737-2017
CS 100 Intra-Aortic Balloon Pump
- FDA Device
- Class I
- terminated
- Published 2017-08-02
On 2017-08-02 the FDA classified a Class I recall of CS 100 Intra-Aortic Balloon Pump by Maquet Datascope Cardiac Assist Division, citing the device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2737-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-06-16 |
| Published | 2017-08-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Maquet Datascope Cardiac Assist Division |
| Distribution | US |
Product
CS 100 Intra-Aortic Balloon Pump
Reason
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
Identifiers
| code_info | 0998-XX-3013-XX, 0998-UC-3013-XX |
|---|
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-2737-2017%22
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