Z-1162-2010

SilverHawk Peripheral Cutter Driver Plaque Excision System REF Catalog No: FG 02550, Sterilized with gamma...

Name: Z-1162-2010 SilverHawk Peripheral Cutter Driver Plaque Excision System REF Catalog No: FG 02550, Sterilized with gamma...
Creator: Ev3, Inc.
Published: 2010-01-21
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2010-01-21 / Terminated / root cause: packaging

FDA source

Ev3, Inc. began a recall of SilverHawk Peripheral Cutter Driver Plaque Excision System REF Catalog No: FG 02550, Sterilized with gamma radiation, Manufacturer ev3 Inc. 4600 Nathan Lane... on 2010-01-21. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1162-2010
Status: Terminated
Initiated: 2010-01-21
Posted: 2010-03-18
Terminated: 2012-04-26
Recalling firm: Medtronic, Inc.
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.
Product code: MCW Catheter, Peripheral, Atherectomy
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.
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: 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.

Product code MCW

K061188Class IISilverhawk Peripheral Plaque Excision SystemFoxhollow Technologies, Inc. / cleared 2006-10-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)