SilverHawk Peripheral Cutter Driver Plaque Excision System recallZ-1162-2010 · Ev3, Inc. · initiated Jan 21, 2010
Terminated All recalls posted in March 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ev3, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Packaging change control
What the company is doing
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.
Recall details
- Recall number
- Z-1162-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 21, 2010
- Posted by the FDA
- Mar 18, 2010
- Recalling firm
- Ev3, Inc.
- Quantity
- 8,330
- Product code
- MCW
- FDA submissions
- K061188
- 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 description
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 (models, lots, serial numbers)
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.
Other devices under the same FDA submission
7 devices cleared under K061188 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SilverHawkTM P4044Covidien LP · Catheter, peripheral, atherectomy7 reports
- SilverHawkTM P4052Covidien LP · Catheter, peripheral, atherectomy7 reports
- SilverHawkTM P4030Covidien LP · Catheter, peripheral, atherectomy6 reports
- SilverHawkTM P4034Covidien LP · Catheter, peripheral, atherectomy4 reports
- SilverHawkTM P4055Covidien LP · Catheter, peripheral, atherectomy4 reports
- SilverHawkTM P4056Covidien LP · Catheter, peripheral, atherectomy2 reports
- SilverHawkTM P4028Covidien LP · Catheter, peripheral, atherectomy1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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