Edwards OptiSite Arterial Cannula Recalled for Exposed Wire Defect
Edwards Lifesciences is recalling OptiSite Arterial Cannulas (Model OPTI18) due to exposed wire protruding from the device body. Approximately 13,240 units distributed worldwide are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, which mandates a minimum severity score of 4 per the rubric. The exposed and protruding wire from the cannula body represents a structural defect in a critical cardiac medical device. No deaths or hospitalizations are reported in the source material.
Plain-English summary
Edwards Lifesciences, LLC is recalling the OptiSite Arterial Cannula, Model OPTI18, used in extracorporeal circulation systems to establish arterial perfusion. The FDA classified this as a Class I recall.
The recall is due to a defect in which a 3 to 4 millimeter section of wire is exposed or protruding from the outside of the cannula body. The manufacturer received complaints regarding this defect.
Approximately 13,240 units have been distributed worldwide, including throughout the United States and to multiple countries internationally.
Individuals with affected devices should contact Edwards Lifesciences for further instructions regarding this recall.
The recalled product
- Product
- Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 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
- structural-defect
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: OPTI18
- UDI: 00690103180565
Distribution
Distributed nationwide across the United States.
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