Sorin Group Aortic Arch Cannula — Class II medical device recall Z-2871-2017
Terminated recall by Sorin Group USA, Inc., reported 2017-08-16, distributed nationwide. Identification of excess plastic on the tip of the cannula.
| Recall number | Z-2871-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin Group USA, Inc., Arvada, CO, United States |
| Recall initiated | 2017-06-09 |
| Classified | 2017-08-10 |
| Reported by FDA | 2017-08-16 |
| Terminated | 2023-11-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, IR, MX, NZ |
| Quantity | 105,770 units |
| Lot numbers | 1407000078, 1705200165, S140979, S141841 |
| Model numbers | NA-1116, NA-1118, NA-1126, NA-1136, NA-1206, NA-1207, NA-1208, NA-1316, NA-1327, NA-1337, NA-1338, RA-1117, RA-1126, RA-1127, RA-1128A, RA-1136, RA-1137, RA-1137A, RA-1138, RA-1206 |
Product
Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Reason for recall
Identification of excess plastic on the tip of the 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-2871-2017. 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.