CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part… — Class II medical device recall Z-1386-2017
Terminated recall by Maquet Datascope Corp - Cardiac Assist Division, reported 2017-03-08, distributed nationwide. Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybri
| Recall number | Z-1386-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Datascope Corp - Cardiac Assist Division, Mahwah, NJ, United States |
| Recall initiated | 2016-12-23 |
| Classified | 2017-03-01 |
| Reported by FDA | 2017-03-08 |
| Terminated | 2019-03-01 |
| Distributed | Nationwide (US) |
| Quantity | 8,000 |
| Model numbers | 0146-00-0097 |
Product
CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons
Reason for recall
Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.
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-1386-2017. 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.