Datascope Intra-Aortic Ballon Catheters — Class II medical device recall Z-2837-2020
Ongoing recall by Datascope Corporation, reported 2020-09-02, distributed nationwide. Potential Endotoxin Contamination
| Recall number | Z-2837-2020 |
|---|---|
| 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 | 69,278 kits |
| Reason classes | sterility |
| Lot numbers | 3000046749, 3000094529, 3000094530, 3000103206, 3000104388, 3000108351, 3000108682, 3000108683, 3000109819, 3000110955, 3000111683, 3000111684, 3000112929, 3000112930, 3000112932, 3000113624, 3000113625, 3000117020 |
Product
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
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-2837-2020. 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.