Edwards Lifesciences recalls Optisite Arterial Cannula model OPTI18 due to 3-4mm wire exposed that 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 OPTI18 because a small wire section can protrude outside the cannula body. This could lead to injury during medical procedures if the cannula is used improperly.
The 3mm to 4mm section of wire can protrude from the cannula body, potentially causing injury during medical procedures. This risk is specific to the device's use in cardiac perfusion circuits where the cannula is inserted into the patient's body.
Medical professionals using the Optisite Arterial Cannula for cardiac procedures are most at risk. Patients receiving this device during surgery may also be affected.
Check for the model number OPTI18 on the device. The serial numbers listed in the recall include specific numbers like 130451, 130466, and BSLC9155. The product was sold with the software version N/A.
Inspect the cannula for a 3mm to 4mm section of wire protruding from the outside of the cannula body.
Reach out to Edwards Lifesciences for guidance on whether the device needs to be replaced or repaired.
The recall indicates a potential risk of injury due to exposed wire, so it is not safe to use without checking for the issue.
Check the device for exposed wire and contact Edwards Lifesciences for guidance on next steps.
Look for the model number OPTI18 and serial numbers listed in the recall, such as 130451 or BSLC9155.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2081-2025 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-2081-2025 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.
