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U.S. Department of Health and Human Services

Class 3 Device Recall IntraCoil Peripheral Stent Vascular

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  Class 3 Device Recall IntraCoil Peripheral Stent Vascular see related information
Date Initiated by Firm April 02, 2008
Date Posted September 11, 2008
Recall Status1 Terminated 3 on December 10, 2011
Recall Number Z-1815-2008
Recall Event ID 48098
PMA Number P000033 
Product Classification Superficial femoral artery stent - Product Code NIP
Product ev3 IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF VT-5-60-135, Lot 4401432, Use Before 2010-07. The IntraCoil is indicated for use in peripheral arteries in the leg in which balloon angioplasty has been applied. The IntaCoil stent is indicated for placement in flexing regions and a tortuous lesion.
Code Information Lot No: 4401432
Recalling Firm/
Manufacturer		 Ev3, Inc
4600 Nathan Ln N
Plymouth MN 55442-2890
For Additional Information Contact
763-398-7000
Manufacturer Reason
for Recall		 Incorrect Label - an IntraCoil 5mm x 40 mm stent was labeled as a 5 mm x 60 mm stent (VT-5-40-135 was labeled as VT-5-60-135).
FDA Determined
Cause 2		 Employee error
Action ev3 representative retrieved from the consignnee the affected device on 4/4/08. A Device Reconcilliation Form was requested to be filled and returned with the product.
Quantity in Commerce 3
Distribution Nationwide Distribution including states of CA and MO.
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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