Events

Recall of PLATINIUM DR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LIVANOVA CANADA CORP..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    151456
  • Event Risk Class
    II
  • Event Initiated Date
    2018-03-14
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    On a subset of platimium icd or crt-d df4 models a component of the df4 connector was identified as potentially defective leading to intermittent loss of contact. as a consequence high values of continuity measures on the defibrillation coils or noise on the right ventricular channel may be observed. this issue can also lead to absence of ventricular pacing therapy and/or inappropriate shock. delivery of defibrillation shock is unaffected.

Device

PLATINIUM DR
  • Model / Serial
    Model Catalog: 1540 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 1841 (Lot serial: 707DD04E); Model Catalog: 1841 (Lot serial: 706DD09E); Model Catalog: 1841 (Lot serial: 702DD04A); Model Catalog: 1841 (Lot serial: 652DD02A); Model Catalog: 1841 (Lot serial: 650DD010); Model Catalog: 1841 (Lot serial: 650DD151); Model Catalog: 1841 (Lot serial: 650DD0F5); Model Catalog: 1841 (Lot serial: 650DD0B2); Model Catalog: 1841 (Lot serial: 650DD1C2); Model Catalog: 1240 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    PLATINIUM DF4 DR ICD;PLATINIUM DF4 SONR CRT-D;PLATINIUM DF4 VR ICD
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

LIVANOVA CANADA CORP.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    HC