Edwards Lifesciences recalls Optisite Arterial Cannula model OPTI16 due to 3-4mm wire exposed/protruding, which 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 Lifesciences is recalling Optisite Arterial Cannula model OPTI16 because a 3-4mm section of wire is exposed or protruding from the cannula body. This could lead to injury during medical procedures if the cannula is used improperly.
The 3-4mm section of wire exposed or protruding from the cannula body could cause injury during medical procedures. This risk is specific to the cannula's use in cardiac perfusion circuits where the wire might snag or cause damage to tissues.
Healthcare professionals using the Optisite Arterial Cannula model OPTI16 for cardiac procedures are most at risk. Patients receiving this cannula during surgery may also be affected.
Check for the model number OPTI16 on the cannula. The affected units have serial numbers listed in the recall notice, including 130467, 130471, and other specific serial numbers provided in the record.
Look for the serial numbers listed in the recall notice, such as 130467, 130471, and others.
The recall indicates a potential risk, but the product is not unsafe for general use. Healthcare professionals should check the serial number to determine if it is affected.
The recall does not specify a remedy, so no action is required unless the serial number matches the listed affected units.
Check the serial number against the list provided in the recall notice, which includes specific numbers like 130467 and 130471.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2080-2025 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-2080-2025 from Edwards Lifesciences. 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.
