Events

Safety Alert for Euphora Semi-Compliant Rapid Exchange Balloon Dilatation 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
    2017-07-14
  • Event Date Posted
    2017-07-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170714.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 euphora semi-compliant rapid exchange balloon dilatation catheter medical device manufacturer, medtronic, has issued a medical device safety alert concerning its euphora semi-compliant rapid exchange (rx) balloon dilatation catheter. the affected devices are identified as follows:- model numbers: eup1506x, eup1510x, eup1512x, eup1515x, eup1520x, eup2006x, eup2010x, eup2012x, eup2015x, eup2020x, eup2025x, eup2030x, eup22506x, eup22510x, eup22512x, eup22515x, eup22520x, eup22525x, eup2506x, eup2510x, eup2512x, eup2515x, eup2520x, eup2525x, eup2530x, eup27506x, eup27510x, eup27512x, eup27515x, eup27520x, eup27525x, eup3006x, eup3010x, eup3012x, eup3015x, eup3020x, eup3025x, eup3030x, eup32506x, eup32510x, eup32512x, eup32515x, eup32520x, eup32525x, eup3506x, eup3510x, eup3512x, eup3515x, eup3520x, eup3525x, eup3530x, eup37506x, eup37510x, eup37512x, eup37515x, eup37520x, eup37525x, eup4006x, eup4010x, eup4012x, eup4015x, eup4020x, eup4025x, eup4030x lot number: 212553130 to 213283557 expiration date: 4 january 2019 to 9 may 2019 the manufacturer has initiated a voluntarily recall of select lot numbers of the medtronic euphora semi-compliant rx balloon dilatation catheter due to reports of difficulties in removing the stylette. in the event, there is the potential for damage to the balloon or catheter due to excessive force being applied, and this may lead to balloon inflation or deflation challenges. potential risks include prolonged procedure time and the need for additional intervention. in addition, inflation or deflation difficulties or catheter damage during procedural use could result in vessel occlusion or injury. according to the manufacturer, they have received one report of patient injury related to this matter. as the issue is experienced at the time of product use, there is no additional action related to the recall for patients who have previously been treated with potentially affected product. the patients should continue to be monitored in accordance with the facility’s standard care protocols. the medtronic nc euphora non-compliant rx balloon dilatation catheters are not affected by the issue. the affected users are advised to immediately stop using devices from the affected lots and return all unused products to the manufacturer for replacement. 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 14 july 2017.

Device

Euphora Semi-Compliant Rapid Exchange Balloon Dilatation Catheter
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Euphora Semi-Compliant Rapid Exchange Balloon Dilatation 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