Recall Z-2085-2025— Edwards Lifesciences, LLC
Class I · Ongoing
Class I FDA medical device recall by Edwards Lifesciences, LLC, initiated 2025-05-14. It names one FDA 510(k) clearance: K140208. Product: Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No. Reason: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body..
- Recalling firm
- Edwards Lifesciences, LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-05-14
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's record- K140208 — FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
Reason for recall
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Data sourced from openFDA. This site is unofficial and independent of the FDA.