The Recall Desk
HighFDA (Devices)·Z-1466-2014·Announced 2014-04-23

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

Edwards Lifesciences is recalling 13,115 Fem-Flex II Arterial and femoral Cannulae because the dilator tips may separate. The recall covers units distributed nationwide and to foreign, government, and military consignees.

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. The hazard involves a structural defect (tip separation) in a medical device used in invasive procedures, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Edwards Lifesciences, LLC is recalling 13,115 units of Fem-Flex II Arterial and femoral Cannulae. The affected products are arterial cannula sizes 16, 18, and 20 French, specifically models FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS. The recall was initiated due to a potential for separation of the dilator tips.

The affected devices were distributed nationwide, including to foreign, government, VA, and military consignees. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.

Healthcare providers and facilities should check their inventory for the specific model numbers and lot codes listed in the recall notice. If the affected devices are found, they should be removed from service and returned to Edwards Lifesciences, LLC in accordance with the company's instructions.

The recalled product

Product
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS.
Manufacturer
Edwards Lifesciences, LLC
Category
Medical Device — Vascular Access
Hazard
Affected units
13,115

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)

  • FEMII016A - 59028126
  • 59049696
  • 59069370
  • 59077178
  • 59090422
  • 59103195
  • 59124013
  • 59138579
  • 59142234
  • 59151373
  • 59176265
  • 59202398
  • 59211445
  • 59218739
  • 59229566
  • 59232164
  • 59240932
  • 59266788
  • 59276834
  • 59312966

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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