Events

Safety Alert for Wingman35 Crossing Catheters

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

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
    2017-05-04
  • Event Date Posted
    2017-05-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170504a.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: reflow medical inc wingman35 crossing catheters the united states food and drug administration (fda) has issued a medical device safety alert concerning wingman35 crossing catheters, manufactured by reflow medical inc. the manufacturer initiated a lot-specific voluntary recall of the wingman35 crossing catheters. the wingman35 crossing catheters have been found to exhibit tip splitting or separation, which has resulted in two adverse events. tip splitting has the potential to lead to loss of device function. tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs. the wingman crossing catheters in this recall were distributed between january 2015 and march 2016. the manufacturer has notified its customers and distributors by recall notification letters. the letters requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected product to the company as soon as possible for credit. for details, please refer to the fda websites: https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm556541.Htm https://www.Fda.Gov/safety/recalls/ucm556525.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 may 2017.

Device

Wingman35 Crossing Catheters

Manufacturer

ReFlow Medical Inc