Events

Safety Alert for FindrWIRZ Guidewire System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Medimaps.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-11-23
  • Event Date Posted
    2016-11-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161123.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: sentreheart findrwirz guidewire system medical device manufacturer, medimaps, has issued a medical device safety alert concerning its tbs insight [software version v.3.0.1]. the united states food and drug administration (fda) has issued medical device safety alerts concerning findrwirz guidewire system, manufactured by sentreheart [product code: 40-05; lot numbers: 01160568, 02160568 and 07160639-150; manufactured between 4 january and 22 july 2016]. the manufacturer is recalling the findrwirz guidewire system because the polytetrafluoroethylene (ptfe) coating may separate (e.G. peel, flake, shed, delaminate, slough off) from the packaging and potentially cause serious injuries to patients. coating separation may be caused by issues with the device design or manufacturing processes. small pieces of the coating could break away and travel elsewhere in the body, or the exposed wire beneath the coating could cause dangerous blood clots in the patient’s bloodstream and can lead to serious adverse health consequences including embolism, stroke, or death. affected users are recommended to take the following actions: identify and stop using the affected products. return the affected products to the manufacturer immediately. for details, please refer to the fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm530413.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm530336.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 november 2016.

Device

FindrWIRZ Guidewire System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: SentreHEART FindrWIRZ Guidewire System
  • Manufacturer
    Medimaps

Manufacturer

Medimaps
  • Source
    DH