Edwards recalls FEM-FLEX II Femoral Arterial Cannula model FEMII016A due to exposed wire sections that could cause injury during medical procedures.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Edwards is recalling FEM-FLEX II Femoral Arterial Cannulas with model number FEMII016A because a 3mm to 4mm section of wire is exposed and protruding. This could lead to injury during medical procedures if the cannula is used improperly.
The 3mm to 4mm section of wire protruding from the cannula body could cause injury if the cannula is handled or used incorrectly during medical procedures. This is a safety concern for healthcare providers who use the device.
Healthcare professionals using the FEM-FLEX II Femoral Arterial Cannula for medical procedures are most at risk due to the exposed wire section.
Check for the model number FEMII016A on the cannula. The product was sold with serial numbers listed in the recall notice, including numbers like 130544 and BSLC8179.
Inspect the cannula for a 3mm to 4mm section of wire protruding from the outside of the cannula body.
The recall states that the product has an exposed wire section that could cause injury during medical procedures, so it is not safe to use without addressing the issue.
The recall does not specify a remedy, so you should check for the exposed wire and contact Edwards Lifesciences for further instructions.
Look for the model number FEMII016A on the cannula, and check if your serial number matches those listed in the recall notice, such as 130544 or BSLC8179.
We’ve drafted a message you can send Edwards to request your refund or repair — edit it as you like.
Subject: Recall Z-2082-2025 — Edwards Edwards Hello, I own a Edwards that is covered by recall Z-2082-2025 from Edwards. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
