Safety Alert for EnVeo R Delivery Catheter System

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

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
  • Event Date Posted
  • Event Country
  • Event Source
  • Event Source URL
  • 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: medtronic enveo r delivery catheter system medical device manufacturer, biomerieux, has issued a field safety notice concerning its etest colistin co256 ww. the affected product reference numbers are 537300 and 537308. medical device manufacturer, medtronic, has issued a medical device safety alert concerning its enveo r delivery catheter system (dcs) [model: enveor-l, enveor-l-c, enveor-us]. the manufacturer is issuing a letter to the health professionals regarding the potential for vascular trauma with the use of the medtronic enveo r delivery catheter system (dcs). while the reports of vascular trauma received by the manufacturer have been infrequent (0.136%; 39 events), they have included serious outcomes, including patient death (0.078%; 19 events). according to the manufacturer, it’s observed rate of 0.136% for vascular trauma is lower than the transcatheter valve therapy (tvt) registry reports in the journal of the american college of cardiology (holmes, et al), which highlighted annular dissection and aortic disruption rates of 0.2% and 0.4% respectively. the manufacturer conducted a thorough investigation and identified recommendations, regarding patient anatomy considerations and procedural uses, to reduce the rate of vascular trauma events according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 august 2016.


  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic EnVeo R Delivery Catheter System
  • Manufacturer