[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
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | 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 or establishes arterial perfusion in the extracorporeal circuit for d 6 |
|---|---|
| Brand / manufacturer | Edwards Lifesciences, LLC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2080-2025 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 14 May 2025 |
| EAN / barcode | 00690103180558 |
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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