CS 100i Intra-Aortic Balloon Pump — Class I medical device recall Z-2736-2017
Terminated recall by Maquet Datascope Corp - Cardiac Assist Division, reported 2017-08-02, distributed nationwide. The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance co
| Recall number | Z-2736-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Datascope Corp - Cardiac Assist Division, Mahwah, NJ, United States |
| Recall initiated | 2017-06-16 |
| Classified | 2017-07-27 |
| Reported by FDA | 2017-08-02 |
| Terminated | 2019-11-29 |
| Distributed | Nationwide (US) |
| Quantity | 12,319 units |
Product
CS 100i Intra-Aortic Balloon Pump
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2736-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.