Edwards recalls FEM-FLEX II Femoral Arterial Cannula model FEMII018A 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 FEM-FLEX II Femoral Arterial Cannulas with model number FEMII018A because a 3mm to 4mm 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 may have a section of wire protruding from the outside, which could cause injury if the cannula is used during medical procedures. This exposure happens due to manufacturing defects in the cannula's design.
Healthcare professionals using the FEM-FLEX II Femoral Arterial Cannula model FEMII018A for medical procedures are affected. Patients receiving this cannula during surgery are at risk of injury from the exposed wire.
Check for the model number FEMII018A on the cannula. The product was sold with serial numbers listed in the recall notice, including numbers like 130468 and BSLC9148.
Inspect the cannula for a 3mm to 4mm section of wire protruding from the outside.
The recall states that some units have exposed wire sections that could cause injury during medical procedures. Use only the unaffected units as described in the recall.
The recall does not specify a remedy, so contact Edwards Lifesciences directly for guidance on whether to stop using the product.
The affected serial numbers include 130468, 130599, 130704, and others listed in the recall notice.
We’ve drafted a message you can send Edwards to request your refund or repair — edit it as you like.
Subject: Recall Z-2084-2025 — Edwards Edwards Hello, I own a Edwards that is covered by recall Z-2084-2025 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.
