Reported Jul 16, 2025 · Ongoing
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A…
Edwards Lifesciences, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- Brand NameFEM-FLEX
- II Product NameFemoral
- Arterial Cannula Model/Catalog NumberFEMII018A
- Software VersionN/A
- Product DescriptionThe Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours
- ComponentNo
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published FEMII018ALot Code — 0069013031256UDI: 0069013031256 — All lots up to: BSLC9148 Serial Numbers: 130468 130599 130704 130848 130953 131048 131286 131430 131626 131774 131775 132004 132005 132510 BSLC0025 BSLC0121 BSLC0422 BSLC1115 BSLC1470 BSLC4161 BSLC4472 BSLC5041 BSLC5293 BSLC5842 BSLC6163 BSLC6164 BSLC7336 BSLC7794 BSLC8660 BSLC9148 - Amount recalled
- 13240
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Stop using this product now
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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