Devices

Device Recall Medtronic SynchroMed implantable drug pump

  • Model / Serial
    All units of these pump models are affected. Updates will be conducted on the Labeling, Training and Education Materials and the Refill Template which is included with the refill kits wil be redesigned.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA including DC and PR and countries including: AUSTRALIA, NEW ZEALAND, HONG KONG, TAIWAN, CHINA, SINGAPORE, MALAYSIA, INDONESIA, SOUTH KOREA, THAILAND, ARUBA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, FAROE ISLANDS, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, ICELAND, INDIA, IRELAND, ISRAEL, ITALY, JAMAICA, JORDAN, KUWAIT, LEBANON, LITHUANIA, LUXEMBOURG, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NETHERLANDS ANTI LES, NORWAY, PANAMA, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, SAN MARINO, SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VATICAN CITY.
  • Product Description
    Medtronic SynchroMed implantable drug pump || Refill Kits (Model No: 8551, 8555, 8561, 8562, 8564, 8565, 8566 || The Model 8551, 8555, 8561, 8562, 8564, 8565, and 8566 Refill Kits are intended for use in refilling Medtronic implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps
  • Manufacturer
    Medtronic, Inc. - Neuromodulation
  • 1 Event

Manufacturer

Medtronic, Inc. - Neuromodulation
  • Manufacturer Address
    Medtronic, Inc. - Neuromodulation, 7000 Central Ave NE, Minneapolis MN 55432-3568
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • 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