Z-0835-2019 Class II Terminated
FDA device recall Z-0835-2019 was initiated by Edwards Lifesciences, LLC on January 22, 2019 and is designated Class II. Reason for recall: This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures. The recall status is terminated (terminated March 26, 2019). Affected quantity: 159,448 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 20, 2019
- Initiation Date
- January 22, 2019
- Termination Date
- March 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 159,448 units
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
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 Pattern
WorldwideDistribution
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