Events

Recall of MECHANICAL HEART VALVE SJM MASTERS SERIES W/SILZONE COAT. MITRAL EXP.

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ST. JUDE MEDICAL INC..

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
    154070
  • Event Risk Class
    I
  • Event Initiated Date
    2000-01-21
  • 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
    Higher incidence of paravalvular leak with silzone coated sewing cuff.

Device

MECHANICAL HEART VALVE SJM MASTERS SERIES W/SILZONE COAT. MITRAL EXP.
  • Model / Serial
    Model Catalog: (Lot serial: 29MECS-602); Model Catalog: (Lot serial: 27MECS-602); Model Catalog: (Lot serial: 25MECS-602); Model Catalog: (Lot serial: 23MECS-602); Model Catalog: (Lot serial: 21MECS-602); Model Catalog: (Lot serial: 19MECS-602); Model Catalog: (Lot serial: 33MECS-602); Model Catalog: (Lot serial: 31MECS-602); Model Catalog: (Lot serial: 19AS-601); Model Catalog: (Lot serial: 21AS-601); Model Catalog: (Lot serial: 23AS-601); Model Catalog: (Lot serial: 25AS-601); Model Catalog: (Lot serial: SARS-40); Model Catalog: (Lot serial: SARS-38); Model Catalog: (Lot serial: SARS-36); Model Catalog: (Lot serial: SARS-34); Model Catalog: (Lot serial: SARS-32); Model Catalog: (Lot serial: SARS-30); Model Catalog: (Lot serial: SARS-28); Model Catalog: (Lot serial: SARS-26); Model Catalog: (Lot serial: SARS-24); Model Catalog: (Lot serial: 33MS-601); Model Catalog: (Lot serial: 31MS-601); Model Catalog: (Lot serial: 29MS-601); Model Catalog: (Lot serial: 27MS-601); Model Catalog:
  • Manufacturer
    ST. JUDE MEDICAL INC.

Manufacturer

ST. JUDE MEDICAL INC.
  • Manufacturer Address
    ST-PAUL
  • Source
    HC