CLASS II Device recall · Reported 24 Apr 2013 · FDA Enforcement Report

Duraflo coated Femoral Cannula recalled by Edwards Lifesciences

Edwards Lifesciences is recalling Duraflo coated Femoral Cannula, distributed nationwide in the US. The recall was initiated on 14 Mar 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel DIIFEMII018A, Lot 59337174

Quantity recalled379 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1111-2013
FDA event ID: 64782
Recalling firm: Edwards Lifesciences, Draper, UT
Classification: Class II
Status: Terminated
Recall initiated: 14 Mar 2013
FDA classified: 14 Apr 2013
Reported: 24 Apr 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

14 Mar 2013	Recall initiated by company
14 Apr 2013	Classified by FDA	+31 days
24 Apr 2013	Published in enforcement report	+10 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The 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. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired. The femoral arterial cannulae are wire-reinforced, thin-wall cannulae.

Where it was distributed

USA Nationwide Distribution including the states of: FL, MA, MI, NY, PA, TX.

Nationwide Florida Massachusetts Michigan New York Pennsylvania Texas

Questions about this recall

Why was it recalled?

Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach.

Which lots are affected?

Model DIIFEMII018A, Lot 59337174

Where was it sold?

USA Nationwide Distribution including the states of: FL, MA, MI, NY, PA, TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Edwards Lifesciences

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20 May 2026Device	CLASS II	Edwards Evoque tricuspid delivery system recalled	Edwards Lifesciences	Other	Nationwide
16 Jul 2025Device	CLASS I	Optisite Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flexii Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide

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