Device Recall Percutaneous Trial Lead Kits

  • Model / Serial
    Material 100077108, Batch 4519182
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of Texas and Illinois.
  • Product Description
    Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). || Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    St. Jude Medical, Inc., 6901 Preston Rd, Plano TX 75024-2508
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Material 100077113, Batch 4558337
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of Texas and Illinois.
  • Product Description
    Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). || Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
  • Manufacturer