The Recall Desk
HighFDA (Devices)·Z-1467-2014·Announced 2014-04-23

Edwards Lifesciences Recalls Fem-Flex II Arterial Cannulae Due to Tip Separation

Edwards Lifesciences is recalling 28,885 Fem-Flex II Arterial and Femoral Cannulae because the dilator tips may separate.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect in a medical device that could cause harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Edwards Lifesciences, LLC is recalling 28,885 units of Fem-Flex II Arterial and Femoral Cannulae with Duraflo Coating. The affected products are arterial cannulae in sizes 16, 18, and 20 French, specifically models DFEMII016AS, DFEMII018AS, DFEMII020AS, DIIFEMII016A, DIIFEMII018A, and DIIFEMII020A.

The recall was initiated due to a potential for the separation of dilator tips. This defect could pose a risk to patients during use. The products were distributed nationwide, including to foreign, government, VA, and military consignees.

Healthcare facilities and consumers should stop using these specific cannulae immediately. Edwards Lifesciences is the recalling firm responsible for managing the recall process.

The recalled product

Product
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16, 18 and 20 French, Models DFEMII016AS, DFEMII018AS, DFEMII020AS, DIIFEMII016A, DIIFEMII018A, and DIIFEMII020A.
Manufacturer
Edwards Lifesciences, LLC
Category
Medical Device — Cannulae
Hazard
Affected units
28,885

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • DFEMII016AS - 59036042
  • 59213298
  • 59258406
  • 59578907
  • DFEMII018AS - 59176126
  • 59249371
  • 59271003
  • 59369527
  • 59374074
  • 59432937
  • 59468460
  • 59484133
  • 59585854
  • 59589948
  • 59645287 DFEMII020AS - 59036043
  • 59113935
  • 59213299
  • 59258407
  • 59320308
  • 59369528

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Edwards Lifesciences, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Edwards Lifesciences, LLC

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Same hazard · structural defect

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