LINEAR 7 — Class II medical device recall Z-0131-2023
Ongoing recall by Datascope Corporation, reported 2022-11-02. The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclos
| Recall number | Z-0131-2023 |
|---|---|
| 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 | 2022-10-24 |
| Reported by FDA | 2022-11-02 |
| Countries outside the US | AE, AR, BR, CA, CL, EC, EG, ES, FR, GB, ID, IL, IT, JO, KE, KR, MX, MY, NL, PK, PL, PT, RU, UY |
| Quantity | 4,414 ous |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10607567106571 |
| Lot numbers | 3000126591, 3000130423, 3000134522, 3000140532, 3000141069, 3000142368, 3000144227, 3000198455, 3000203002, 3000210758, 3000210759 |
| Model numbers | 0684-00-0480-02 |
Product
LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
Reason for recall
The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable.
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-0131-2023. 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.