MEGA 8Fr 50cc Intra-Aortic Balloon Catheter — Class II medical device recall Z-1685-2022
Ongoing recall by Datascope Corporation, reported 2022-09-14. Certain lots containing undersized dilator.
| Recall number | Z-1685-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corporation, Fairfield, NJ, United States |
| Recall initiated | 2022-08-05 |
| Classified | 2022-09-08 |
| Reported by FDA | 2022-09-14 |
| Countries outside the US | AE, AU, BE, CA, CH, CZ, DE, ES, FR, GB, HK, IE, IS, IT, NL, NO, NZ, PL, PT, SA, SE, SI, ZA |
| Quantity | 10,427 units |
| UPC / GTIN / UDI-DI | 10607567107301, 10607567109619 |
| Model numbers | 0684-00-0296-01U, 10607567109619, 3000184437 |
Product
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Reason for recall
Certain lots containing undersized dilator.
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-1685-2022. 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.