Agency classClass IIOur severity:High FDA (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.

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, 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: structural-defect
tip-separation
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 →

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