Arterial Cannula Recalled Due to Exposed Wire Protruding from Cannula
Edwards Lifesciences is recalling Optisite Arterial Cannula units due to wire sections 3-4mm in length protruding from the cannula body, posing a patient injury risk.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification indicates this recall involves an imminent hazard to health or safety. The exposed wire protruding from the cannula creates a direct mechanical risk to patient safety during device use.
Plain-English summary
Edwards Lifesciences, LLC is recalling Optisite Arterial Cannula units (Model OPTI16) due to complaints of wire—3-4mm in length—exposed or protruding from the outside of the cannula body. This defect was identified through customer complaints.
The product is a cardiac cannula used to establish arterial perfusion in extracorporeal circuits. Approximately 27,022 units were distributed worldwide, including to all 50 U.S. states and multiple countries in Europe, Asia, the Americas, and Africa.
Affected units are Model OPTI16 with lot codes through BSLC9149. The exposed wire creates a direct mechanical risk to patients during device use.
The recalled product
- 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 extracorpo
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- exposed-wire
- mechanical-hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Code: Model No:OPTI16
- UDI: 00690103180558
Distribution
Distributed nationwide across the United States.
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