Events

Recall of SYMPLICITY RENAL DENERVATION CATHETER

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
    17440
  • Event Risk Class
    II
  • Event Initiated Date
    2013-01-24
  • 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
    Medtronic has identified an issue with the symplicity model rdn006 catheter cable connectors which may prevent therapy delivery. the symptoms include: o a flickering generator display screen upon initial catheter connection o generator status display of "check connection" o rapid fluctuations in the temperature reading o multiple early termination of energy delivery accompanied by "check status" safety codes 22 23 and/or 32 despite confirming electrode placement as defined by the ifu. this issue is isolated to the catheter and does not impact the rf generator. medtronic is distributing this notification to inform of methods to detect the failure and guidance to minimize inconveniences.

Device

SYMPLICITY RENAL DENERVATION CATHETER
  • Model / Serial
    Model Catalog: RDN006 (Lot serial: > 10 lot numbers contact mfg)
  • Product Description
    SYMPLICITY RENAL DENERVATION CATHETER
  • 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