Events

Field Safety Notices about Euphora and Solarice Rapid Exchange Balloon Dilatation Catheters

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Medtronic Ireland Limited.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-07-13
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    This communication is to inform you of a voluntary recall of select lot numbers of the medtronic euphora™ and solarice™ semi-compliant rapid exchange (rx) balloon dilatation catheter due to reports of difficulties in removing the stylette. availability of each of these products will vary by geography. a summary of the model numbers and lot numbers affected by this issue can be found in appendix a of this communication. the medtronic nc solarice™ and nc euphora™ non- compliant rx balloon dilatation catheters are not affected by this issue. the total number of customer reports relating to removal difficulties associated with this generation of medtronic semi-compliant rx catheters represent 0.1% of all affected units manufactured and distributed (since 12 january 2017). medtronic has received one (1) report of patient injury related to this matter. .

Device

Euphora and Solarice Rapid Exchange Balloon Dilatation Catheters

Manufacturer

Medtronic Ireland Limited
  • 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
    AMPMDRS