Cardiohelp Emergency Drive — Class I medical device recall Z-0986-2019
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2019-04-03, distributed nationwide. Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, lead
| Recall number | Z-0986-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States |
| Recall initiated | 2019-02-08 |
| Classified | 2019-03-28 |
| Reported by FDA | 2019-04-03 |
| Terminated | 2020-05-14 |
| Distributed | Nationwide (US) |
| Quantity | 10 |
| Serial numbers | 90420231, 90420359, 90420455, 90420904, 90421188, 90421204, 90421228, 90421279, 90421304, 90421761 |
| Model numbers | 70104.8002 |
Product
Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
Reason for recall
Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency Drive.
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-0986-2019. 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.