18 Fr 6mm Sft Flow Angled Wire The Sarns Aortic Cannula is indicated… — Class II medical device recall Z-0459-2013
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-12-12, distributed in AL, CA, CO, DC, DE, FL, GA, IL…. The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The
| Recall number | Z-0459-2013 |
|---|---|
| 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 | 2012-11-21 |
| Classified | 2012-12-03 |
| Reported by FDA | 2012-12-12 |
| Terminated | 2013-04-23 |
| Distributed | AL, CA, CO, DC, DE, FL, GA, IL, IN, KS, KY, LA, MA, MI, MO, MS, MT, NC, ND, NE, NH, NY, OH, PA, TN, TX, VA, WI |
| Countries outside the US | AE, AU, BE, CA, JP, MY, SG |
| Quantity | 5,760 total |
| Reason classes | device malfunction |
| Lot numbers | 0597322, 0602541, 0610241, 0615610, 0619197, 0620809, 0620810 |
| Model numbers | 7071 |
Product
18 Fr 6mm Sft Flow Angled Wire The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Reason for recall
The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptabl
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-0459-2013. 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.