Events

Recall of COOL-TIP RF SINGLE ELECTRODE KIT

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

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
    134567
  • Event Risk Class
    I
  • Event Initiated Date
    2012-08-08
  • 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 recall is being conducted due to the potential for foil degradation on the dgphp rfa high-powerr single use grounding pads. this foil degradation may result in an electrical disconnect and undesirable thermal profile during use which may result in a serious burn at the patient pad site.

Device

COOL-TIP RF SINGLE ELECTRODE KIT
  • Model / Serial
    Model Catalog: SWCT15303 (Lot serial: >10 see with manufacturer); Model Catalog: SWCT1530 (Lot serial: >10 see with manufacturer); Model Catalog: ACTC2025 (Lot serial: >10 see with manufacturer); Model Catalog: ACTC1525 (Lot serial: >10 see with manufacturer); Model Catalog: ACTC1025 (Lot serial: >10 see with manufacturer); Model Catalog: ACT2530 (Lot serial: >10 see with manufacturer); Model Catalog: ACT2030 (Lot serial: >10 see with manufacturer); Model Catalog: ACT2020 (Lot serial: >10 see with manufacturer); Model Catalog: ACT1530 (Lot serial: >10 see with manufacturer); Model Catalog: ACT1520 (Lot serial: >10 see with manufacturer); Model Catalog: ACT1510 (Lot serial: >10 see with manufacturer); Model Catalog: ACT1507 (Lot serial: >10 see with manufacturer); Model Catalog: ACT1030 (Lot serial: >10 see with manufacturer); Model Catalog: ACT1020 (Lot serial: >10 see with manufacturer); Model Catalog: SWCT1540 (Lot serial: >10 see with manufacturer); Model Catalog: SWCT2530 (Lot serial: >10 see with manufa
  • Product Classification
    General and Plastic Surgery Devices
  • Product Description
    COOL-TIP RF SINGLE ELECTRODE KIT
  • Manufacturer
    COVIDIEN

Manufacturer

COVIDIEN
  • Manufacturer Address
    SAINT-LAURENT
  • 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