Device Recall 1500T9 Cardiac Ablation Generator

  • Model / Serial
    T9 Generator - Catalog 1500T9/Model IBI-89000. Serial numbers: 13826729 and 13827596.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution, including the states of Kansas and Maryland.
  • Product Description
    The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part of the Therapy Cardiac Ablation System, along with the Cool Point irrigation Pump, the Therapy 1300 Series Steerable Ablation Catheters, the Therapy Cool Path Ablation Catheters and accessories. The generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output delivered from the generator between its tip electrode and a dispersive pad for the treatment of atrial flutter.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    St Jude Medical Inc, 177 E County Road B, Saint Paul MN 55117-1951
  • 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