Optisite OPTI18 arterial cannulas may have wire protruding from the body
Edwards Optisite OPTI18 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. 13,240 units affected.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 OPTI18, UDI 00690103180565, a cardiac cannula that provides or establishes arterial perfusion, is being recalled. The action covers 13,240 units, comprising all lots up to BSLC9155.
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: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the…
- Manufacturer
- Edwards Lifesciences, LLC
- Affected units
- 13,240
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
Part of a larger recall action
This product is one of 6 recalled by Edwards Lifesciences, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Edwards Lifesciences, LLC
See all →- ModerateEdwards EVOQUE Tricuspid Delivery System Labeling Update for Valve Functionality
FDA (Devices) · 2026-05-20
- SevereFEM-FLEX II FEMII018AS cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereFEM-FLEX II femoral arterial cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereFEM-FLEX II FEMII016A cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereFEM-FLEX II FEMII018A cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
Same hazard · protruding wire
See all →- SevereOptisite OPTI16 arterial cannulas may have wire protruding from the body
FDA (Devices) · 2025-07-16
Similar recalls
- HighEdwards Lifesciences Recalls Aortic Perfusion Cannulas Due to Cracks
FDA (Devices) · 2013-11-13
- SevereEdwards Lifesciences Recalls EZ Glide Aortic Cannula Due to Connector Separation Risk
FDA (Devices) · 2019-11-27
- HighEdwards Lifesciences Recalls Fem-Flex II Arterial Cannulae Due to Tip Separation
FDA (Devices) · 2014-04-23
- HighArterial Cannula Recall: EOPA 3D 22FR May Develop Pinhole Leaks During Bypass
FDA (Devices) · 2026-08-05
- ModerateSPS Sterilization Recalls Resterilized Edwards Arterial Perfusion Cannula
FDA (Devices) · 2018-09-19
- HighArterial Cannula Recalled Due to Pinhole Leaks During Cardiopulmonary Bypass
FDA (Devices) · 2026-08-05