Edwards Lifesciences, LLC: Medical Device Recall in 2013 - (Recall #: Z-0135-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 26, 2013

Date Posted: November 13, 2013

Recall Number: Z-0135-2014

Event ID: 66112

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.

Status: Terminated

Product Quantity: 140 units

Code Information:

Lot number 59261626 expiry 06/01/15

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated