Edwards Certitude Delivery System Recalled for Molding Overflow Defect
Edwards Lifesciences is recalling 1,730 units of the Certitude Delivery System due to a molding overflow defect that could detach and embolize into patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a defect could cause harm (embolization) to a patient, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Edwards Lifesciences, LLC is recalling 1,730 units of the Certitude Delivery System and associated Multipacks (Models 9600CT20A, 9600CT23A, 9600CT26A, and 9600CT29A). The recall is due to a potential molding overflow defect in the Certitude Loader component.
The defect could cause the component to detach during the advancement of the delivery system. If this occurs, the detached material could potentially embolize from the loader into the patient. The affected products are used for the delivery of the Edwards SAPIEN 3 transcatheter heart valve, typically during a transapical or transaortic approach to transcatheter aortic valve replacement.
The affected units were distributed to all United States states except Alaska, Hawaii, Idaho, New Mexico, Rhode Island, South Dakota, and Wyoming. Healthcare providers should stop using the affected devices and contact Edwards Lifesciences for further instructions.
The recalled product
- Product
- Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), typically during a transapical (TA) o
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Cardiovascular
- Affected units
- 1,730
Distribution
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