Events

Safety Alert for INSIGNIA pacemakers, NEXUS pacemakers, CONTAK RENEWAL TR CRT-Ps, CONTAK RENEWAL TR 2 CRT-Ps, VENTAK PRIZM 2, ICDs, VITALITY ICDs, and VITALITY 2 ICDs

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

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
    2006-06-27
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20060627.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
    Press release
  • Reason
    Voluntary recall of heartbeat regulating products 27 june 2006 (tuesday) the department of health (dh) received notification from a medical device manufacturing company about a voluntary recall of a number of devices used for regulating heartbeats, including cardiac pacemakers, cardiac resynchronization therapy pacemakers (crt-ps), and cardioverter defibrillators (icds). the notification from guidant hong kong limited involved the following products - insignia pacemakers, nexus pacemakers, contak renewal tr crt-ps, contak renewal tr 2 crt-ps, ventak prizm 2, icds, vitality icds, and vitality 2 icds. it was found that five devices did not function as a result of failure of the capacitor leading to intermittent or permanent loss of output or premature battery depletion. to date, about 49 800 devices have been distributed and approximately 27 200 devices have been implanted worldwide. there have been two overseas reports of pacemaker patients experiencing syncope. there have been no other reported serious incidents locally, no reports of adverse incidents have been received by dh. according to guidant hong kong limited, i n hong kong , 32 devices have been implanted in hospitals under hospital authority (ha) and private hospitals. guidant has contacted ha and related doctors to advise them to follow up patients in their clinics as soon as possible. individual patients implanted with affected devices should contact their attending doctors immediately if they have symptoms. patients may call guidant hong kong limited's hotline at 2593 2206 for enquiry. the dh has informed public and private hospitals, and medical professional associations about this recall action and advise them to take necessary follow up actions. dh welcomes the timely actions taken by guidant as a responsible manufacturer to issue this recall.

Device

INSIGNIA pacemakers, NEXUS pacemakers, CONTAK RENEWAL TR CRT-Ps, CONTAK RENEWAL TR 2 CRT-Ps, VENT...
  • Model / Serial
  • Product Description
    Press release: Voluntary Recall of Heartbeat Regulating Products
  • Manufacturer
    Guidant Hong Kong Limited

Manufacturer

Guidant Hong Kong Limited
  • 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