Sarns flexible arterial cannula — Class II medical device recall Z-0668-2013
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2013-01-23, distributed nationwide. Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the
| Recall number | Z-0668-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2013-01-07 |
| Classified | 2013-01-11 |
| Reported by FDA | 2013-01-23 |
| Terminated | 2013-08-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BH, BR, CA, CL, HN, SG, TT, TW |
| Quantity | 6,830 all |
| Reason classes | device malfunction |
| Lot numbers | 0677287, 0681074 |
| Model numbers | 13030 |
Product
Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Reason for recall
Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
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-0668-2013. 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.