Events

Safety Alert for Amphirion Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation Catheter

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

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
    2015-10-26
  • Event Date Posted
    2015-10-26
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151026.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: medtronic amphirion deep percutaneous transluminal angioplasty (pta) balloon dilation catheter medical device manufacturer, medtronic, has issued a medical device safety alert concerning its amphirion deep percutaneous transluminal angioplasty (pta) balloon dilation catheter. the affected products are identified as follow: model number:amd015020002, amd020120152, amd025150152, amd030150152, amd040120002, amd335210002, amd015020151, amd020150002, amd030040002, amd035040152, amd040120152, amd335210152, amd015020152, amd020150152, amd030040152, amd035120002, amd040150002, amd354210002, amd020040002, amd025040152, amd030080002, amd035150002, amd040150152, amd354210152, amd020040152, amd025080152, amd030080152, amd035150152, amd225210002, amd020080002, amd025120002, amd030120002, amd040040152, amd225210152, amd020080152, amd025120152, amd030120152, amd040080002, amd253210002, amd020120002, amd025150002, amd030150002, amd040080152, amd253210152 medtronic is conducting a voluntary urgent medical device recall of the affected products due to a potential breach of pouch seal for the product manufactured in select lots. according to the manufacturer, they did not receive any customer complaint or report of adverse patient events regarding improperly sealed pouches. the potential for the breach in the pouch enclosing the sterilized product was discovered during internal packaging testing, which involved exposure to extreme use conditions. the manufacturer requests the customers to identify and quarantine all unused, affected product in their inventory, and return them to the manufacturer. patients who have received treatment with the devices affected by the recall should continue to be monitored in accordance with the physician’s standard practice. 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 26 october 2015.

Device

Amphirion Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation Catheter
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic Amphirion Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation Catheter
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH