Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model:… recallZ-2435-2018 · Edwards Lifesciences, LLC · initiated Jun 11, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Edwards Lifesciences, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
FDA root cause category: Labeling False and Misleading
What the company is doing
On 06/11/2018, the firm sent an Urgent Product Recall notice, via sales representative hand delivery, to the customer requesting they return the customer response form and the affected device. The customer was advised to call Customer Service at 1-800-424-3278, if they had any additional questions.
Recall details
- Recall number
- Z-2435-2018
- Status
- Terminated
- Initiated by the company
- Jun 11, 2018
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 1 Valve
- Product code
- NPT
- FDA submissions
- P140031
- Distribution
- NJ
Product description
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Code information (models, lots, serial numbers)
Use By: 2020-01-24, Serial #: 6005731, UDI #: (01)00690103194357(17)200124(21)6005731
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFXEdwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered1 recall22 deaths733 reports
Product lines
Other devices under the same FDA submission
22 devices cleared under P140031 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 9750TFX26Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered64 deaths1,070 reports
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 9750TFX23Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered42 deaths936 reports
- SAPIEN 3 Ultra System 9750CM26Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered26 deaths531 reports
- SAPIEN 3 Ultra RESILIA 9755RSL29Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered35 deaths321 reports
- SAPIEN 3 Ultra RESILIA 9755RSL26Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered18 deaths314 reports
- SAPIEN 3 Ultra System 9750CM23Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered22 deaths290 reports
- SAPIEN 3 Ultra RESILIA 9755RSL23Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered20 deaths202 reports
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 9750TFX20Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered9 deaths141 reports
- COMMANDER 9750CM29Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered13 deaths139 reports
- EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS26Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered1 recall1 death25 reports
- EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS23Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered1 recall1 death6 reports
- SAPIEN 3 Ultra System 9750CM20Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered2 deaths55 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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