24FR FLEX ART CANN NON STERILE — Class II medical device recall Z-1839-2012

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-1839-2012`
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	`0550551`, `0568495`, `0576844`, `0586459`, `0601958`, `0626874`, `0635682`
Model numbers	`88813030`

Product

24FR FLEX ART CANN NON STERILE. 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

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-1839-2012. 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.