Events

Recall of SYNCHROMED II - PROGRAMMABLE PUMP

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
    28375
  • Event Risk Class
    I
  • Event Initiated Date
    2017-04-27
  • 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
    This notice provides an update to information previously communicated to physicians in july 2011 regarding the failure rate for reduced battery performance in medtronic model 8637 synchromed ii pumps manufactured through june 2011. this notice reinforces previously communicated patient management recommendations related to this issue. this notification does not apply to synchromed ii devices currently being marketed or implanted or to any previously implanted devices manufactured after june 2011. medtronic previously issued a notification regarding the potential for sudden loss of therapy due to reduced battery performance from the formation of a resistive film in a small percentage of synchromed ii pumps with batteries manufactured prior to july 2011. performance monitoring of the affected pump population has since found a higher-than-predicted failure rate in a subset of affected pumps manufactured between january 2011 and june 2011.

Device

SYNCHROMED II - PROGRAMMABLE PUMP

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