Events

Safety Alert for AngioJet Ultra Catheters

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

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
    2015-08-11
  • Event Date Posted
    2015-08-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150811.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: boston scientific angiojet ultra catheters medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its angiojet ultra catheters. the affected devices are identified as follow:- spiroflex angiojet thrombectomy set [material number 106553-004; lot 163580] angiojet solent omni [material number 109681-004, 109681-001; lot 162185, 162318] angiojet solent dista [material number 111303-001; lot 161905] avx thrombectomy set [material number 105039-001; lot 163390] boston scientific, in cooperation with bayer medical care, is initiating a recall on distributed product in the scope of a 2014 bayer interventional angiojet recall. the bayer interventional recall was initiated due to units having incorrect 'use by' dates on the label that were one month beyond the actual use by date. the correct use by date is 2015-11 (november 30, 2015) but the date on the label is 2015-12 (december 31, 2015). the affected products are still within their valid shelf-life through november 30, 2015. no adverse health consequence is reasonably expected to result from the incorrect use by date. the eopa arterial cannula is intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration. this cannula features a dilator tip introducer to facilitate cannula insertion and priming. the introducer features a guidewire port for use with a 0.038” guidewire. as indicated in the instructions for use (ifu) a guidewire must be used for proper placement of the introducer tip while inserting the cannula to avoid trauma to the back wall of the aorta. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 august 2015.

Device

AngioJet Ultra Catheters
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific AngioJet Ultra Catheters
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH