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
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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
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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
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For Additional Information Contact |
Sarah Huoh 949-250-6864
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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.
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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
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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.
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PMA Database |
PMAs with Product Code = NPT and Original Applicant = EDWARDS LIFESCIENCES, LLC.
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