Device Recall SilverHawk Peripheral Cutter Driver Plaque Excision System

  • Model / Serial
    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 Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Ev3, Inc., 4600 Nathan Ln N, Plymouth MN 55442-2890
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA