Recall of Edwards Commander Delivery System models due to reported balloon component separation during TAVR procedures. Affected units include specific model numbers and UDI numbers.
This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.
Edwards Lifesciences is recalling its Commander Delivery System for potential balloon component separation during TAVR procedures. This could lead to complications during heart valve replacement surgery.
During TAVR procedures, the crimp balloon and inflation balloon components may separate, which could cause complications in the surgery. This separation might lead to improper valve deployment or other surgical issues.
Patients undergoing TAVR (transcatheter aortic valve replacement) procedures who have the specific model numbers and UDI numbers listed are affected. Medical professionals using the system for these procedures are at risk.
Check the model number and UDI number on the product label. Affected models include 9600LDS20A, 9600LDS20J, 9600LDS23A, 9600LDS23J, 9600LDS26A, 9600LDS26J, 9600LDS29A, 9600LDS29J, 9610TF20, 9610TF23, 9610TF26, and 9610TF29 with specific UDI numbers.
Look for the model number and UDI number on the product label to determine if it is affected.
Contact Edwards Lifesciences directly to confirm if your specific model is affected and to get further instructions.
The recall addresses reported cases of crimp balloon and inflation balloon component separation during TAVR procedures, which could lead to complications in heart valve replacement surgery.
Affected models include 9600LDS20A, 9600LDS20J, 9600LDS23A, 9600LDS23J, 9600LDS26A, 9600LDS26J, 9600LDS29A, 9600LDS29J, 9610TF20, 9610TF23, 9610TF26, and 9610TF29 with specific UDI numbers.
The recall does not require immediate stop use; however, affected users should check their product label and contact Edwards Lifesciences to confirm if their model is affected.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0835-2019 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-0835-2019 from Edwards Lifesciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
