Events

Safety Alert for ICD TELIGEN, Model Nos.: F102, F103, F110, F111 and CRT-D COGNIS, Model Nos.: P107 and P108

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
    2012-03-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120314a.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 icd teligen, model nos.: f102, f103, f110, f111 and crt-d cognis, model nos.: p107 and p108 it comes to our attention that the state institute for drug control, czech republic received information from boston scientific that the below implantable cardioverter-defibrillator (icd) and defibrillator for cardiac resynchronization therapy (crt-d) were stolen from the service car of clinical engineer on march 01, 2012 in the territory of the czech republic. trade name model no. material no. serial no. expiration date icd teligen_he vr df1 f102 60f102-814 113139 4.8.2012 icd teligen_he vr df1 f102 60f102-814 114621 9.12.2012 icd teligen_he vr df4 f103 60f103-805 116879 16.12.2012 icd teligen_he dr df1 f110 60f110-814 117249 10.8.2012 icd teligen_he dr df4 f111 60f111-805 104766 6.7.2012 icd teligen_he dr df4 f111 60f111-805 104769 6.7.2012 crt-d cognis_he df1/is1 p107 60p107-814 113354 14.5.2012 crt-d cognis_he df1/is1 p107 60p107-814 115530 29.7.2012 crt-d cognis_he df4 p108 60p108-805 107564 4.10.2012 crt-d cognis_he df4 p108 60p108-805 107572 4.10.2012 crt-d cognis_he df4 p108 60p108-805 107921 10.11.2012 if you are in possession of the affected product, please contact boston scientific for necessary actions.

Device

ICD TELIGEN, Model Nos.: F102, F103, F110, F111 and CRT-D COGNIS, Model Nos.: P107 and P108
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific ICD TELIGEN, Model Nos.
  • 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