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Terminated

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 Recall Z-0134-2014 · Posted 2013-11-01

Recalling FirmEdwards Lifesciences, LLC
Recall StatusTerminated
Product CodeDWF
Date Initiated2013-08-26
Date Terminated2017-02-22
Product Quantity80 units

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.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123370EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULAEdwards Lifesciences, LLC · 2013-03-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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