Optisite OPTI16 arterial cannulas may have wire protruding from the body
Edwards Optisite OPTI16 Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 27,022 units 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: FDA Class I recall, which the rubric floors at Severe; no injury is reported in the source, so it does not escalate to Critical.
Plain-English summary
The Optisite Arterial Cannula, model number OPTI16, UDI 00690103180558, a cardiac cannula that provides or establishes arterial perfusion, is being recalled. The action covers 27,022 units, comprising all lots up to BSLC9149.
The stated reason is complaints received for a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. The FDA classified the action as Class I, its most serious classification.
Distribution was worldwide, including nationwide in the United States. The cannulas are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the model number, UDI and lot range above, quarantine it, and follow the instructions issued by Edwards.
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
- protruding-wire
- cannula-defect
- perfusion
- class-i
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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