Events

Recall of SPRINT FIDELIS STEROID ELUTING - TRIPOLAR - VENTRICULAR LEAD

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDTRONIC OF CANADA LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    31598
  • Event Risk Class
    III
  • Event Initiated Date
    2011-04-01
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    It is no longer a recommended option to implant a pace-sense lead while maintaining use of the fidelis high voltage conductors after a fidelis pace-sense conductor fracture has occurred.

Device

SPRINT FIDELIS STEROID ELUTING - TRIPOLAR - VENTRICULAR LEAD
  • Model / Serial
    Model Catalog: 6930 (Lot serial: LFK004984V LFK005530V); Model Catalog: 6930 (Lot serial: LFK001689V LFK003047V); Model Catalog: 6930 (Lot serial: LFK001690V LFK004992V); Model Catalog: 6930 (Lot serial: S/N'S LFK004993V LFK004820V); Model Catalog: 6931 (Lot serial: CONTACT); Model Catalog: 6931 (Lot serial: MANUFACTURER); Model Catalog: 6931 (Lot serial: >1000 NUMBERS); Model Catalog: 6949 (Lot serial: MANUFACTURER); Model Catalog: 6949 (Lot serial: >1000 NUMBERS); Model Catalog: 6949 (Lot serial: CONTACT); Model Catalog: 6948 (Lot serial: MANUFACTURER); Model Catalog: 6948 (Lot serial: >100 NUMBERS); Model Catalog: 6948 (Lot serial: CONTACT)
  • Product Description
    SPRINT FIDELIS STEROID ELUTING - TRIPOLAR
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Manufacturer Address
    BRAMPTON
  • 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
    HC