EDWARDS COMMANDER DELIVERY SYSTEM recallZ-0835-2019 · Edwards Lifesciences, LLC · initiated Jan 22, 2019
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
This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.
FDA root cause category: Labeling design
What the company is doing
The firm began disseminating the notices by letter on 01/22/2019. The notices explained the issue and advised the consignee to follow the guidelines and instructions provided in the Edward SAPIEN3 Commander delivery system training material for device preparation and use. Updated instructions for use will be disseminated in the near future.
Recall details
- Recall number
- Z-0835-2019
- Status
- Terminated
- Initiated by the company
- Jan 22, 2019
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 159,448 units
- Product code
- NPT
- FDA submissions
- P140031
- Distribution
- WorldwideDistribution
Product description
Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 00690103194869 9600LDS26A (US) 00690103193954 9600LDS26J 00690103194876 9600LDS29A (US) 00690103193961 9600LDS29J 00690103194883 9610TF20 00690103192995 9610TF23 00690103190458 9610TF26 00690103190465 9610TF29 00690103193008 Product Usage: The Edwards SAPIEN 3 THV, Edwards Commander delivery system and accessories are indicated for use in patients with severe, symptomatic, calcific aortic stenosis
Code information (models, lots, serial numbers)
(ALL LOTS Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 00690103194869 9600LDS26A (US) 00690103193954 9600LDS26J 00690103194876 9600LDS29A (US) 00690103193961 9600LDS29J 00690103194883 9610TF20 00690103192995 9610TF23 00690103190458 9610TF26 00690103190465 9610TF29 00690103193008
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS29Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered1 recall17 deaths225 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
- EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS20Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered1 recall5 reports
Product lines
Other devices under the same FDA submission
20 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
- SAPIEN 3 Ultra System 9750CM20Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered2 deaths55 reports
- SAPIEN 3 Ultra RESILIA 9755RSL20Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered4 deaths44 reports
- EDWARDS CERTITUDE DELIVERY SYSTEM 9600SDS26Edwards Lifesciences LLC · Prosthesis, Mitral Valve, Percutaneously Delivered9 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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