Events

Safety Alert for RX Accunet Embolic Protection System

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

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
    2011-11-29
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111129c.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
    Field safety notice: abbott vascular rx accunet embolic protection system medical device manufacturer, abbott vascular, has issued a field safety notice concerning the rx accunet embolic protection system. abbott vascular has discovered that certain lots may exhibit difficult removal of the peel away sheath due to a higher than normal wall thickness. there have been no adverse patient effects reported as a result of this issue. this action does not affect patients having successfully undergone endovascular carotid procedures. however, if an affected device is used it may result in difficulty initiating the peel away sheath, possibly resulting in additional device maneuvers and or a delay in procedure. this action does not affect any inventory beyond the units identified here. according to the local supplier, hong kong is not affected. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

RX Accunet Embolic Protection System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott Vascular RX Accunet Embolic Protection System
  • Manufacturer
    Abbott Vascular

Manufacturer

Abbott Vascular
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH