Aortic Arterial Cannula 22 Fr — Class II medical device recall Z-2160-2018
Terminated recall by Maquet Cardiopulmonary Ag, reported 2018-06-20, distributed in PR. This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the
| Recall number | Z-2160-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiopulmonary Ag, Rastatt, N/A, Germany |
| Recall initiated | 2018-05-14 |
| Classified | 2018-06-11 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2020-05-15 |
| Distributed | PR |
| Countries outside the US | AE, AU, BE, BR, CA, CH, CL, CO, CY, CZ, DE, DK, EE, EG, ES, FI, FR, GB, IE, IL, IR, IT, JP, LB, MX, MY, NL, NO, NZ, PK, PL, PT, RS, RU, SA, SE, SG, SK, TH, TR, ZA |
| Quantity | 470 us |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04037691123813 |
| Lot numbers | 92181287, 92181729 |
| Model numbers | 701002246 |
Product
Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass
Reason for recall
This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.
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-2160-2018. 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.