Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Edwards Commander Delivery System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Edwards Commander Delivery System see related information
Date Initiated by Firm January 22, 2019
Create Date February 14, 2019
Recall Status1 Terminated 3 on March 26, 2019
Recall Number Z-0835-2019
Recall Event ID 81924
PMA Number P140031 
Product Classification Aortic valve, prosthesis, percutaneously delivered - Product Code NPT
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
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 
Recalling Firm/
Manufacturer		 Edwards Lifesciences, LLC
12050 S Lone Peak Pkwy
Draper UT 84020-9414
For Additional Information Contact Sarah Huoh
949-250-6864
Manufacturer Reason
for Recall		 This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.
FDA Determined
Cause 2		 Labeling design
Action 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.
Quantity in Commerce 159,448 units
Distribution WorldwideDistribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = NPT and Original Applicant = EDWARDS LIFESCIENCES, LLC.
-
-