Events

Safety Alert for OffRoad Re-Entry Catheter System

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
    2014-09-11
  • Event Date Posted
    2014-09-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140911a.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 offroad re-entry catheter system medical device manufacturer, boston scientific, has issued a field safety notice (fsn) concerning its offroad re-entry catheter system, with the following details: material no.: h74939202070540 catalog no.: 39202-100540 lot no.: 16949014 (expiration date on outer carton: may 2017); 16805826 (expiration date on outer carton: march 2017); 16514008 (expiration date on outer carton: november 2016); 16514006 (expiration date on outer carton: november 2016); 16548224 (expiration date on outer carton: october 2016) the offroad re-entry catheter system consists of two components, which are contained in an outer carton: the offroad positioning balloon catheter and the offroad micro-catheter lancet. the manufacturer has become aware that the outer package carton for these five lots displays an incorrect expiration date that is two months past the actual expiration date. the actual expiration of the individual positioning balloon catheter and micro-catheter lancet contained within the outer carton is correctly displayed on the pouch and box labels of those components. no adverse health consequence is expected to occur from this issue. the manufacturer has not received any complaints for the incorrect expiration date. affected users are advised to immediately discontinue use of, segregate and return affected products. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 sep 2014.

Device

OffRoad Re-Entry Catheter System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific OffRoad Re-Entry Catheter System
  • 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