Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: structural-defect
tip-separation
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 →

Same manufacturer · Edwards Lifesciences, LLC

See all →

Moderate
Edwards EVOQUE Tricuspid Delivery System Labeling Update for Valve Functionality
FDA (Devices) · 2026-05-20
Severe
FEM-FLEX II FEMII016A cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
Severe
FEM-FLEX II femoral arterial cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
Severe
FEM-FLEX II FEMII018A cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
Severe
Optisite OPTI18 arterial cannulas may have wire protruding from the body
FDA (Devices) · 2025-07-16

Same hazard · structural defect