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U.S. Department of Health and Human Services

Class 2 Device Recall SilverHawk Peripheral Cutter Driver Plaque Excision System

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  Class 2 Device Recall SilverHawk Peripheral Cutter Driver Plaque Excision System see related information
Date Initiated by Firm January 21, 2010
Date Posted March 18, 2010
Recall Status1 Terminated 3 on April 26, 2012
Recall Number Z-1162-2010
Recall Event ID 52299
510(K)Number K061188  
Product Classification Atherectomy Peripheral Catheter - Product Code MCW
Product SilverHawk¿ Peripheral Cutter Driver Plaque Excision System
REF Catalog No: FG 02550, Sterilized with gamma radiation, Manufacturer ev3 Inc. 4600 Nathan Lane North, Plymouth, MN 55442, Manufactured at : 9775 Toledo Way, Irvine, CA 92618.,

Intended for use in atherectomy of the peripheral vasculature. The catheter is NOT intended for use in the coronary or carotid vasculature.
Code Information 7341279, 7426555, 7516513, 7584246, 7366716, 7470350, 7526519, 7696072, 7373759, 7481467, 7536344,  7381976, 7497872, 7555071,  7408387, 7505507, 7574961,    7341279, 7505507, 7555071,  7381976, 7516513, 7574961,  7408387, 7536344, 7696072,  7426555, 7481467,  7470350, and 7497872.  
Recalling Firm/
Manufacturer		 Ev3, Inc.
4600 Nathan Ln N
Plymouth MN 55442-2890
For Additional Information Contact
763-398-7000
Manufacturer Reason
for Recall		 ev3 Inc. is conducting a voluntary recall of specific lots of the SilverHawk¿ Cutter Drivers (Model Number FG 02550) because of damage to the packaging.
FDA Determined
Cause 2		 Packaging change control
Action Consignees were sent an ev3 "Medical Device Recall" letter dated January 21, 2010. The letter was addressed to Cath Lab Manger/Risk Manager. The letter described the Issue Summary, Affected Product, and Required Action. The letter instructed customers to locate and remove from use the specified Cutter Driver(s). Customers are to complete and return the "Device Recall Field Action Reconciliation Form." An ev3 rep will assist in arranging for the return of all unused product and a replacement will be provided. Questions regarding the recall should be directed to ev3 Customer Service at 1-800-716-6700.
Quantity in Commerce 8,330
Distribution Worldwide Distribution -- USA, with the exception of AK and VT, and countries of AUSTRIA, BELGIUM, BRAZIL, CANADA, CHINA, CZECH REPUBLIC, FRANCE, GERMANY, INDIA, IRELAND, ISRAEL, ITALY, JORDAN, LEBANON, POLAND, SAUDI ARABIA, SOUTH KOREA, SPAIN, SWEDEN, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
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.
510(K) Database 510(K)s with Product Code = MCW and Original Applicant = FOXHOLLOW TECHNOLOGIES, INC.
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