Events

Rappel de PRECISE PRO RX NITINOL STENT SYSTEM -40MM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par CARDINAL HEALTH CANADA INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    53524
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-05-06
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    Based on recent complaints and subsequent investigation cordis has determined that products made between april 27 2015 and november 22 2015 have been associated with an increased frequency of incidents of deployment difficulty and in some instances outer member shaft separation resulting in inability to deploy the stent or partial stent deployment. product manufactured after november 22 2015 including product currently manufactured and supplied are not affected. there have been no patient injuries reported to us related to this issue. however considering the products risk analysis the potential impact of inability to deploy the stent or partial stent deployment include an intra-procedural delay while a replacement device is prepared vessel damage requiring unplanned percutaneous or surgical intervention to prevent permanent injury or impairment or in most severe cases transient ischemic attack or stroke.

Device

PRECISE PRO RX NITINOL STENT SYSTEM -40MM
  • Modèle / numéro de série
    Model Catalog: PC1040XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0740XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0840XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0940XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0640XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0540XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0720XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0820XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC1030XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0930XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0830XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0730XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0630XCE (Lot serial: > 10 NUMBERS CONTACT MFG)
  • Description du dispositif
    PRECISE PRO RX NITINOL STENT SYSTEM -40MM;PRECISE PRO RX NITINOL STENT SYSTEM - 20MM;PRECISE PRO RX NITINOL STENT SYSTEM - 30MM
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Cardinal Health
  • Source
    HC