Edwards recalls FEM-FLEXII Femoral Arterial Cannula model FEMII018AS due to exposed wire sections that may 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 femoral arterial cannula model because a small section of wire can protrude from the outside. This could lead to injury during medical procedures if the wire gets caught or cut.
The cannula has a section of wire that can protrude from the outside. If this wire gets caught or cut during medical procedures, it could cause injury to the patient or medical staff.
Medical professionals using the FEM-FLEXII Femoral Arterial Cannula model FEMII018AS for procedures. Patients undergoing surgery with this cannula may be at risk if the wire causes injury.
Check for the model number FEMII018AS on the cannula. The product was sold with serial numbers starting from 131776 up to BSLC9064.
Inspect the cannula for any sections of wire that protrude 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.
Check for exposed wire sections and contact Edwards Lifesciences for further instructions.
Look for the model number FEMII018AS on the cannula, and check if the serial number starts from 131776 up to BSLC9064.
We’ve drafted a message you can send Edwards to request your refund or repair — edit it as you like.
Subject: Recall Z-2085-2025 — Edwards Edwards Hello, I own a Edwards that is covered by recall Z-2085-2025 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.
