Datascope Intra-Aortic Ballon Catheters — Class II medical device recall Z-2842-2020
Ongoing recall by Datascope Corporation, reported 2020-09-02, distributed nationwide. Potential Endotoxin Contamination
| Recall number | Z-2842-2020 |
|---|---|
| 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 | 3,059 kits |
| Reason classes | sterility |
| Lot numbers | 3000051381, 3000053316, 3000057969, 3000062074, 3000062557, 3000062558, 3000064524, 3000066987, 3000066988, 3000066989, 3000066990, 3000067890, 3000069733, 3000074397, 3000074398, 3000077670, 3000077671, 3000078857, 3000080306, 3000080310, 3000083334, 3000083335, 3000084272, 3000084969, 3000087490, 3000087491, 3000092779, 3000092780, 3000095470, 3000096586, 3000098053, 3000098054, 3000098055, 3000098056, 3000099590, 3000099591, 3000107761, 3000107762, 3000112273, 3000112274 |
Product
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Kit P/N: 0684-00-0546-01
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-2842-2020. 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.