Arterial Cannula recalled due to Risk of Wire Exposure, United States

United States

Edwards Lifesciences has issued a recall for specific models of its arterial cannula due to the risk of wire exposure. The affected products were distributed nationwide in the United States and may pose serious health risks if used. The FDA has issued a highest-level recall for this device, warning that its use could result in significant injury or potentially be life-threatening.

REASON FOR RECALL:
Edwards Lifesciences has discovered that, in some cases, a 3mm to 4mm segment of wire from the reinforcement coil near the tip of certain OptiSite Arterial Perfusion Cannulas may become exposed and detach from the main body of the cannula. Because certain Femoral Arterial Cannula models use the same materials and construction, those models are also being included in the recall as a precaution.

Using a device with an exposed wire may present serious patient risks, including significant tissue injury, arterial puncture that could lead to bleeding, insufficient blood flow, and damage to red blood cells (hemolysis).

AFFECTED PRODUCTS:
1) PRODUCT: OptiSite Arterial Perfusion Cannula
- Model Number: OPTI16
- UDI-DI: 00690103180558

2) PRODUCT: OptiSite Arterial Perfusion Cannula
- Model Number: OPTI18
- UDI-DI: 00690103180565

3) PRODUCT: Peripheral Femoral Arterial Cannula
- Model Number: FEMII016A
- UDI-DI: 00690103031232

4) PRODUCT: Peripheral Femoral Arterial Cannula
- Model Number: FEMII016AS
- UDI-DI: 00690103168341

5) PRODUCT: Peripheral Femoral Arterial Cannula
- Model Number: FEMII018A
- UDI-DI: 00690103031256

6) PRODUCT: Peripheral Femoral Arterial Cannula
- Model Number: FEMII018AS
- UDI-DI: 00690103168358

The issue was discovered when sections of wire were found exposed at the cannula tip. The recall, classified as Class I by the FDA, was initiated on May 16, 2025.

If you or a loved one are harmed or experiencing any symptoms, it is important to report it. Reporting can help to detect & resolve outbreaks early and prevent others from being harmed, and enables better surveillance. If symptoms persist, seek medical care.

Source: www.fda.gov/medical-devices/medical-device-recalls/arterial-cannula-recall-edwards-lifesciences-removes-arterial-cannula-due-risk-wire-exposure