—#170314

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

FDA product code: NPT — Aortic Valve, Prosthesis, Percutaneously Delivered
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P140031
Affected 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

Why it was recalled

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

Root cause (FDA determination)

Labeling design

Action the firm took

The firm began disseminating the notices by letter on 01/22/2019. The notices explained the issue and advised the consignee to follow the guidelines and instructions provided in the Edward SAPIEN3 Commander delivery system training material for device preparation and use. Updated instructions for use will be disseminated in the near future.

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 12050 S Lone Peak Pkwy, Draper, Utah 84020-9414

Distribution

Distribution pattern: WorldwideDistribution

Timeline

Recall initiated: 2019-01-22
Terminated: 2019-03-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170314. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.