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.
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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient."
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)…
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Cardiovascular
- Affected units
- 1,730
Distribution
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 FEMII016A cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereOptisite OPTI16 arterial cannulas may have wire protruding from the body
FDA (Devices) · 2025-07-16
- SevereFEM-FLEX II femoral arterial cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereOptisite OPTI18 arterial cannulas may have wire protruding from the body
FDA (Devices) · 2025-07-16
Same hazard · embolization
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighFDA Recalls Vascular Access Device Due to Loose Metal Shavings Risk
FDA (Devices) · 2024-05-15
- HighVascular access device recalled due to loose metal shavings
FDA (Devices) · 2024-05-15
- HighMedical Device Recall: Angiodynamics DURAMAX Tunneler with Metal Shavings
FDA (Devices) · 2024-05-15
- HighHemodialysis vascular access kit recalled due to metal shavings risk
FDA (Devices) · 2024-05-15
Similar recalls
- SevereEdwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons
FDA (Devices) · 2019-08-28
- ModerateEdwards SAPIEN 3 Transcatheter Heart Valve Recalled for Incorrect Size Labeling
FDA (Devices) · 2018-07-25
- HighEdwards Lifesciences IntraClude Intra-Aortic Occlusion Device Recalled for Potential Damage
FDA (Devices) · 2015-06-17
- HighEdwards Commander Delivery System Recalled for Balloon Component Separation
FDA (Devices) · 2019-02-20
- HighEdwards Recalls EndoReturn Arterial Cannula Due to Component Error
FDA (Devices) · 2013-08-21
- HighEdwards IntraClude Intra-Aortic Occlusion Device Recalled for Potential Leak
FDA (Devices) · 2018-05-30