Datascope System 98/98xt — Class I medical device recall Z-1523-2014
Terminated recall by Maquet Datascope Corp - Cardiac Assist Division, reported 2014-05-28, distributed nationwide. Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure coul
| Recall number | Z-1523-2014 |
|---|---|
| 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 | 2014-03-21 |
| Classified | 2014-05-21 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2018-03-20 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
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 for recall
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.
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-1523-2014. 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.