Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo… — Class II medical device recall Z-0135-2014

Terminated recall by Edwards Lifesciences, LLC, reported 2013-11-13, distributed nationwide. Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in

Recall number	`Z-0135-2014`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Edwards Lifesciences, LLC, Draper, UT, United States
Recall initiated	2013-08-26
Classified	2013-11-01
Reported by FDA	2013-11-13
Terminated	2017-02-22
Distributed	Nationwide (US)
Quantity	140 units
Reason classes	packaging
Lot numbers	`59261626`
Expiration dates	`2015-06-01`

Product

Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only, Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6Fr to 18Fr can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.

Reason for recall

Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation.

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-0135-2014. 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.