—#121499

Product

Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards Lifesciences femoral access cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Femoral access cannulae may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K123370
Affected lot / code info: Lot number 59388992 expiry 1/1/16

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

Edwards sent an Urgent Field Safety Notice Product Recall letter dated August 26, 2013 to all affected customer, via Fed-Ex. The product is sold directly to hospitals and distributors. The distributors involved will communicate with their customers directly. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their entire inventory, quarantine and return the affected products. An acknowledgement form is included for completion to assist in the assessment of the inventory. For questions contact Edwards Customer Service at 800-424-3278.

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 12050 Lone Peak Pkwy, Draper, Utah 84020-9414

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2013-08-26
Posted by FDA: 2013-11-01
Terminated: 2017-02-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121499. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.