Edwards Lifesciences, LLC: Medical Device Recall in 2019 - (Recall #: Z-0835-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: January 22, 2019

Date Posted: February 20, 2019

Recall Number: Z-0835-2019

Event ID: 81924

Reason for Recall:

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

Status: Terminated

Product Quantity: 159,448 units

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

Voluntary or Mandated:

Voluntary: Firm initiated