Events

Field Safety Notices about VALITUDE™, VISIONIST™ CRT-P and CHARISMA™ , MOMENTUM™, RESONATE™, VIGILANT™, AUTOGEN™, DYNAGEN™, INOGEN™, ORIGEN™ CRT-D

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Boston Scientific.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

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Device

VALITUDE™, VISIONIST™ CRT-P and CHARISMA™ , MOMENTUM™, RESONATE™, VIGILANT™, AUTOGEN™, DYNAGEN™, ...

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
    HPRA