Edwards recalls FEM-FLEX II Femoral Arterial Cannula model FEMII016AS 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 a specific model of femoral arterial cannula because a small section of wire may be exposed on the outside. This could lead to injury during medical procedures if the cannula is used improperly.
The cannula has a section of wire that protrudes from the outside, which could cause injury if the cannula is handled or moved during medical procedures. This exposure is a safety concern in clinical settings where precise handling is required.
Healthcare professionals using the FEM-FLEX II Femoral Arterial Cannula model FEMII016AS for medical procedures are most at risk. Patients receiving this cannula during surgery or critical care may also be affected.
Check for the model number FEMII016AS on the cannula packaging or label. The product was sold with serial numbers starting with FEMII016AS and was used in medical procedures for up to 6 hours.
Inspect the cannula for a 3mm to 4mm section of wire protruding from the outside.
The product may have an exposed wire section that could cause injury during medical procedures, so it is not safe to use without checking for the issue.
The recall does not specify a remedy, so contact Edwards Lifesciences directly for guidance on whether to stop using it.
Look for the model number FEMII016AS on the cannula or its packaging.
We’ve drafted a message you can send Edwards to request your refund or repair — edit it as you like.
Subject: Recall Z-2083-2025 — Edwards Edwards Hello, I own a Edwards that is covered by recall Z-2083-2025 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.
