Covidien

  • Model / Serial
    Al lot codes
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Chile Philippines Taiwan Australia New Zealand.
  • Product Description
    Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected || Part Number: 22660PC
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Covidien LLC, 15 Hampshire St, Mansfield MA 02048-1113
  • Manufacturer Parent Company (2017)
  • 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
    USFDA

259 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model: 8LPC and 8LPC-S, Affected: Lots between 0910000346 and 1101001823, and 110200327X and 120600351X (8LPC); 0910001002 and 1103002052, and 111000400X and 120600014X (8LOC-S)
  • Product Classification
  • Manufacturer
  • Model / Serial
    Model: 8FEN, Affected: Lots between 0910000342 and 1101001558; and 110201893x and 120600700x
  • Product Classification
  • Manufacturer
  • Model / Serial
    Model: SWCT1530, SWCT15303, SWCT1540, SWCT2530, SWCT25303, SWCT2540, Affected: Various lots
  • Manufacturer
  • Model / Serial
    Model: ACT1020, ACT1030, ACT1507, ACT1510, ACT1520, ACT1530, ACT2020, ACT2030, ACT2530, ACTC1025, ACTC1525, ACTC2025, DGPHP, Affected: Selected lots
  • Manufacturer
  • Model / Serial
    Model: DUET4535, DUET4535A, DUET4548, DUET4548A, DUET6036, DUET6035A, DUET6048, DUET6048A, Affected: all serail.lot numbers
  • Manufacturer
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