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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm April 28, 2005
Date Posted May 18, 2005
Recall Status1 Terminated 3 on October 16, 2012
Recall Number Z-0849-05
Recall Event ID 32030
Product Classification Stent, Coronary - Product Code MAF
Product Edwards LifeStent NT Self-Expanding Stent and Delivery System;
Models: NT186901(D); NT187901(D); NT186902(D); NT187902(D); NT356901(D); NT357901(D);NT356902; NT357902(D)
Code Information All codes.
Recalling Firm/
Manufacturer		 Edwards Lifesciences Llc
One Edwards Way
Irvine CA 92614-5688
For Additional Information Contact Dana Rodriguez
949-250-2459
Manufacturer Reason
for Recall		 Potential for deployment difficulties.
FDA Determined
Cause 2		 Other
Action Recall was by voice mail and regular postal service on 4/28/2005 in the USA, in Europe recall began May 2, 2005. Recall notification is complete, unused product is being returned.
Quantity in Commerce 537
Distribution Nationwide and Europe
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.
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