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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 Recall
IntraCoil Peripheral Stent Vascular
see related information
Date Posted September 11, 2008
Recall Status1 Open
Recall Number Z-1815-2008
Recall Event ID 48098
Premarket Approval
PMA Number
P000033
Product Classification Stent, Superficial Femoral Artery - 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, Minnesota 55442-2890
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
TRAINING: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = NIP and Applicant = EV3 INC
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