Datascope Intra-Aortic Ballon Catheters — Class II medical device recall Z-2840-2020
Ongoing recall by Datascope Corporation, reported 2020-09-02, distributed nationwide. Potential Endotoxin Contamination
| Recall number | Z-2840-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corporation, Fairfield, NJ, United States |
| Recall initiated | 2020-07-27 |
| Classified | 2020-08-21 |
| Reported by FDA | 2020-09-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BE, BR, CA, CH, CL, CO, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IL, IN, IT, JP, KE, KR, MX, NG, NL, NO, NZ, PL, PT, PY, RS, RU, SE, SG, SK, TH, TR, TW, UY, ZA |
| Quantity | 116,652 kits |
| Reason classes | sterility |
| Lot numbers | 3000046499, 3000046733, 3000046737, 3000046814, 3000047059, 3000047198, 3000047201, 3000047274, 3000047275, 3000047353, 3000047356, 3000047604, 3000047637, 3000047706, 3000047708, 3000048026, 3000048223, 3000048230, 3000048400, 3000048401, 3000048959, 3000048960, 3000048961, 3000048962, 3000049055, 3000049208, 3000049310, 3000049313, 3000049421, 3000049722, 3000049723, 3000050258, 3000050669, 3000051066, 3000051122, 3000051151, 3000051152, 3000051378, 3000051647, 3000051995 and 352 more |
Product
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-0480-02, 0684-00-0480-02C, 0684-00-0480-02U, 0684-00-0480-07, 0684-00-0480-08, 0684-00-0480-10
Reason for recall
Potential Endotoxin Contamination
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-2840-2020. 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.