Recall Z-2081-2025— Edwards Lifesciences, LLC

Name: FDA recall Z-2081-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-14

Class I · Ongoing

Class I FDA medical device recall by Edwards Lifesciences, LLC, initiated 2025-05-14. It names one FDA 510(k) clearance: K073559. Product: Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite 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

K073559 — 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA IIEdwards Lifesciences Research Medical·cleared 2008-01-31

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: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite 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.