Device 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.
Z-0135-2014
Product summary
- Event
- Event 66112
- Status
- Terminated
- Classification
- Class II
- Quantity
- 140 units
- Official record key
device-enforcement:Z-0135-2014
Official wording
Reason: 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.
Code information: Lot number 59261626 expiry 06/01/15
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
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.