Edwards Lifesciences, LLC: Medical Device Recall in 2013 - (Recall #: Z-1111-2013)

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 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.

Product Classification:

Class II

Date Initiated: March 14, 2013

Date Posted: April 24, 2013

Recall Number: Z-1111-2013

Event ID: 64782

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.

Status: Terminated

Product Quantity: 379 units

Code Information:

Model DIIFEMII018A, Lot 59337174

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated