Events

Recall of ECHELON 60 ENDOPATH STAPLER ENDOSCOPIC LINEAR CUTTER RELOADS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    27025
  • Event Risk Class
    II
  • Event Initiated Date
    2013-05-27
  • 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
    Ethicon is initiating a worldwide recall for echelon 60mm endoscopic linear cutter reloads black (ecr60t) due to the potential for incomplete staple line formation from reload damage during the firing sequence. this may result in insufficient tissue apposition that could require surgical intervention to help achieve and maintain anastomotic integrity.

Device

ECHELON 60 ENDOPATH STAPLER ENDOSCOPIC LINEAR CUTTER RELOADS

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.