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[Recalled] Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductBrand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 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
Brand / manufacturerEdwards Lifesciences, LLC
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2080-2025
Country of noticeUnited States
Risk levelClass I
Hazard typerecall
Notice date14 May 2025
EAN / barcode00690103180558

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

Read the full official notice →

Related recalls from Edwards Lifesciences, LLC

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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