Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada has posted a medical device safety alert concerning Taewoong Medical Co., Ltd. Niti-S Bronchial Uncovered Stent [Both Flare Type] [Model or Catalogue Number: BR1404W, BR1204W; Lot or Serial Number: 21E1330AABR024, 20G0629BBBR016, 21J4136BBBR015, 21L3221BKBR017, 20E5694AKBR011] [HKMD No.: 190326].
According to Health Canada, some of the specifications for the Niti-S Bronchial Uncovered Stent [Both Flare Type] (BRxxxxW) do not meet the company's standards. There is a possibility that some of these devices within the expiration date (3 years from manufacturing date) may not perform as intended due to the under performance of expansion and compression.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/niti-s-bronchial-uncovered-stent-both-flare-type
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 Apr 2024