Source: US Department of Health and Human Services – 3
This recall involves removing devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
Product Family
Model Number
UDI-DI
OptiSite Arterial Perfusion Cannula
OPTI16
00690103180558
OptiSite Arterial Perfusion Cannula
OPTI18
00690103180565
Peripheral Femoral Arterial Cannula
FEMII016A
00690103031232
Peripheral Femoral Arterial Cannula
FEMII016AS
00690103168341
Peripheral Femoral Arterial Cannula
FEMII018A
00690103031256
Peripheral Femoral Arterial Cannula
FEMII018AS
00690103168358
What to Do
Do not use the identified affected products listed in the table above.
On May 16, 2025, Edwards Lifesciences began sending all affected customers a “Field Corrective Action #192” letter recommending the following actions:
Search your inventory for and remove the affected product.
Share this notice with appropriate clinical staff at your site.
Ensure no patient follow-up or notification is necessary.
Work with your Edwards enableCV (eCV) Representative to return affected product and receive a credit.
Distributors should notify all customers who have purchased the affected product by sending the customer notification they received.
Reason for Recall
Edwards Lifesciences has identified occurrences in which a 3mm to 4mm section of wire, from the wire-reinforcement coil at the cannula tip of the OptiSite Arterial Perfusion Cannula devices, was found to be exposed (released from the cannula body). Since some Femoral Arterial Cannula models are made of the same components as the impacted OptiSite Arterial Perfusion Cannula, Edwards has included those Femoral Arterial Cannula models as affected product to be removed from use.
Risks to the patient of using the affected product with exposed wire include major tissue damage, puncturing the artery which could cause bleeding, inadequate perfusion, and hemolysis.
As of May 20, 2025, Edwards Lifesciences has not reported any serious injuries or deaths associated with this issue.
Device Use
The Edwards Lifesciences arterial perfusion cannulae are indicated for adult patients undergoing cardiopulmonary bypass. They are intended to provide arterial perfusion of oxygenated blood in the extracorporeal circuit for up to six hours.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact their Edwards eCV Representative or Edwards Customer Service at FCA_ECV@edwards.com or 888-943-2783.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Content current as of:
07/24/2025
Regulated Product(s)