SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6 — Class II medical device recall Z-1833-2012
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-06-27, distributed nationwide. During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo
| Recall number | Z-1833-2012 |
|---|---|
| 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 | 2012-05-09 |
| Classified | 2012-06-20 |
| Reported by FDA | 2012-06-27 |
| Terminated | 2013-07-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BR, CA, CL, DE, HK, HN, IN, JP, NI, PH, SA, SG, TH, TT, TW, VN, ZA |
| Quantity | 133,793 |
| Lot numbers | 0551680, 0553010, 0557571, 0559882, 0562967, 0566831, 0569995, 0575870, 0579316, 0584969, 0589928, 0593454, 0595251, 0601331, 0606816, 0611597, 0617494, 0622167, 0626795, 0629156, 0632515, 0636330, 0640190, 0643858, 0649159, 0652241, 0656575, 0663510, 621463C |
| Model numbers | 12325 |
Product
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Reason for recall
During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the parti
Machine access
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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.