Events

Safety Alert for Imager™ II Catheter (Urology)

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
    2012-03-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120322b.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: boston scientific imager™ ii catheter (urology) medical device manufacturer, boston scientific, has issued a field safety notice concerning imager ii™ catheter (urology). boston scientific has found that, during shipping, some units in the 5-pack box may experience a physical interaction between the carton and the area on the pouch where the hub is located. this interaction was found to cause pinholes in the sterile barrier pouch of affected products. the investigation found that these pinholes are not likely to be detected by visual inspection. 13 complaints have been received from imager pouch damage issues and no adverse health consequence is reasonably expected to occur from these pinholes. according to the local supplier, the affected product is not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

Imager™ II Catheter (Urology)
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific Imager™ II Catheter (Urology)
  • 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