BIOTRONIK CANADA INC

  • Manufacturer Address
    TORONTO
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    HC
  • 3 Events

3 devices in the database

  • Model / Serial
    Model Catalog: 390741 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 390721 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 390681 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 390691 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 390701 (Lot serial: > 10 lot numbers contact mfg)
  • Product Description
    PULSAR-18 PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM
  • Model / Serial
    Model Catalog: 389791 (Lot serial: >100 numbers contact mfg); Model Catalog: 389788 (Lot serial: >100 numbers contact mfg); Model Catalog: 389787 (Lot serial: >100 numbers contact mfg); Model Catalog: 389786 (Lot serial: >100 numbers contact mfg); Model Catalog: 389785 (Lot serial: >100 numbers contact mfg); Model Catalog: 389784 (Lot serial: >100 numbers contact mfg); Model Catalog: 389783 (Lot serial: >100 numbers contact mfg); Model Catalog: 389782 (Lot serial: >100 numbers contact mfg); Model Catalog: 389781 (Lot serial: >100 numbers contact mfg)
  • Product Description
    GALEO PRO CORONARY GUIDEWIRE
  • Model / Serial
    Model Catalog: 351456 (Lot serial: >10 numbers contact mfg); Model Catalog: 351455 (Lot serial: >10 numbers contact mfg); Model Catalog: 351457 (Lot serial: 01109002); Model Catalog: 351457 (Lot serial: 08099006); Model Catalog: 351457 (Lot serial: 10099008); Model Catalog: 351457 (Lot serial: 10099007); Model Catalog: 351457 (Lot serial: 01109001); Model Catalog: 351459 (Lot serial: 02109003); Model Catalog: 351459 (Lot serial: 9099001); Model Catalog: 351459 (Lot serial: 10099001); Model Catalog: 351459 (Lot serial: 10099003); Model Catalog: 351458 (Lot serial: >10 numbers contact mfg)
  • Product Description
    CRUISER HYDRO CORONARY AND PERIPHERAL ARTERY GUIDE WIRE F