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.
FDA Recall Z-1162-2010 · Posted 2010-03-18
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Recalling FirmEv3, Inc.
Recall StatusTerminated
Product CodeMCW
Date Initiated2010-01-21
Date Terminated2012-04-26
Product Quantity8,330
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.
Firm 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.
Root Cause
Packaging change control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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