Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-1111-2013

March 14, 2013

Class II

Product summary

Firm
Edwards Lifesciences, LLC
Event
Event 64782
Status
Terminated
Classification
Class II
Quantity
379 units
Official record key
device-enforcement:Z-1111-2013

Official wording

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

Code information: Model DIIFEMII018A, Lot 59337174

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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