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 0069010
Check against the official notice below — it lists the full affected range.
Edwards Lifesciences, LLC has recalled Edwards Commander Delivery System devices due to reports of crimp balloon and inflation balloon component separation occurring during TAVR (transcatheter aortic valve replacement) procedures. The recall affects 159,448 units of multiple model numbers distributed worldwide, including models 9600LDS20A, 9600LDS20J, 9600LDS23A, 9600LDS23J, 9600LDS26A, 9600LDS26J, 9600LDS29A, 9600LDS29J, 9610TF20, 9610TF23, 9610TF26, and 9610TF29 across all lots.
The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.
Reason for recall: This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures. Distribution: WorldwideDistribution Quantity: 159,448 units Lot/code info: (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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.