Events

Recall of PRECISE PRO RX NITINOL STENT SYSTEM -40MM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDINAL HEALTH CANADA 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
    53524
  • Event Risk Class
    II
  • Event Initiated Date
    2016-05-06
  • 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
    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
  • Model / Serial
    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)
  • Product Description
    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.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    HC