Events

Recall of PROSTAJECT INJECTOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AMERICAN MEDICAL SYSTEMS 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
    16801
  • Event Risk Class
    II
  • Event Initiated Date
    2001-09-14
  • 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
    The needle being deployed fully went in through the prostrate and out laterally into the muscle of the bladder then injected ethanol spread and caused a ring of necrosis.

Device

PROSTAJECT INJECTOR
  • Model / Serial
    Model Catalog: 72403224 (Lot serial: ALL LOTS); Model Catalog: 72403225 (Lot serial: ALL LOTS); Model Catalog: 72403226 (Lot serial: ALL LOTS); Model Catalog: 72403228 (Lot serial: ALL LOTS); Model Catalog: 72403227 (Lot serial: ALL LOTS)
  • Product Description
    PROSTAJECT ETHANOL INJECTING SYSTEM
  • Manufacturer
    AMERICAN MEDICAL SYSTEMS INC

Manufacturer

AMERICAN MEDICAL SYSTEMS INC
  • Manufacturer Address
    MINNETONKA
  • Source
    HC