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U.S. Department of Health and Human Services

Class 3 Device Recall IntraCoil

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  Class 3 Device Recall IntraCoil see related information
Date Initiated by Firm April 09, 2008
Date Posted September 21, 2008
Recall Status1 Terminated 3 on May 27, 2009
Recall Number Z-1816-2008
Recall Event ID 48102
PMA Number P000033 
Product Classification peripheral vascular stent - Product Code NIP
Product ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF VT-6-60-135, Lot 4401214, Use Before 2010-07.
Code Information Lot 4401214
Recalling Firm/
Manufacturer		 Ev3, Inc
4600 Nathan Ln N
Plymouth MN 55442-2890
For Additional Information Contact
763-398-7000
Manufacturer Reason
for Recall		 An IntraCoil 6 mm x 40 mm stent was labeled as a 6 mm x 60 mm stent.
FDA Determined
Cause 2		 Labeling mix-ups
Action ev3 representative visited the consignee on 4/15/08 and spoke to the physician at the site that used the device. A Device Recall Field Action Reconcilliation Form was requested.
Quantity in Commerce 1
Distribution CA
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 = NIP and Original Applicant = MEDTRONIC VASCULAR INC
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