Optisure Dual Coil Defibrillation Lead

Manufacturer

  • 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
    AFMPS

4 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Description
    St. Jude Medical: Optisure dual coil defibrillation lead
  • Manufacturer
  • Model / Serial
    LDA 220 Q52, LDA 220 Q58, LDA 220 Q65 and LDP 220 Q58 | Total of 1121 leads are affected. Of which 164 have been implanted or are in hospital inventory outside US.
  • Product Classification
  • Product Description
    AIMD: Endocardial defibrillation lead
  • Manufacturer
  • Model / Serial
    Optisure Dual Coil Defibrillation Leads(Lead, defibrillator/pacemaker, implantable)Model Numbers: LDA220Q/52, LDA220Q/58, LDA220 Q/65 and LDP 220Q/58ARTG Numbers: 221010, 221013 and 221011
  • Product Classification
  • Manufacturer