SARNS ANTEGRADE: CARDIOPLEGIA CANNULA: ROOT INFUSION VENT/CATHETER… — Class II medical device recall Z-1876-2012
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-07-04, distributed nationwide. During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) iden
| Recall number | Z-1876-2012 |
|---|---|
| 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 | 2012-06-27 |
| Reported by FDA | 2012-07-04 |
| Terminated | 2013-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BE, BR, DO, HN, JP, MX, MY, NI, SA, SG, TH, TT, VN, ZA |
| Quantity | 53,139 |
| Lot numbers | 0551678, 0557083, 0561754, 0562984, 0568008, 0572137, 0575072, 0580833, 0583190, 0586161, 0591033, 0596204, 0605323, 0612587, 0615536, 0619196, 0622171, 0627245, 0631928, 0632342, 0639031, 0641468, 0648454, 0650700, 0652249, 0653439, 0660677, 593715C |
| Model numbers | 203887 |
Product
SARNS ANTEGRADE: CARDIOPLEGIA CANNULA: ROOT INFUSION VENT/CATHETER WITH 14- GAUGE WHITE NEEDLE, RECTANGULAR FLANGE, 6" (15 CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.
Reason for recall
During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. 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
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.