Device product

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

Z-0835-2019

January 22, 2019

Class II

Product summary

Firm: Edwards Lifesciences, LLC
Event: Event 81924
Status: Terminated
Classification: Class II
Quantity: 159,448 units
Official record key: device-enforcement:Z-0835-2019

Official wording

Reason: This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.

Code information: (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

Distribution pattern: WorldwideDistribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.