Events

Field Safety Notices about certain lots of 9Fr ACUITY Pro Coronary Sinus Outer Guide Catheters

According to Bundesinstitut für Arzneimittel und Medizinprodukte, this field safety notices involved a device in Germany 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.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    09365/15
  • Date
    2015-12-11
  • Event Country
    Germany
  • Event Source
    BAM
  • Event Source URL
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/01/2015/09365-15_kundeninfo_en.html
  • Notes / Alerts
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
  • Extra notes in the data

Device

certain lots of 9Fr ACUITY Pro Coronary Sinus Outer Guide Catheters
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Active implantable medical devices - implantable leads
  • 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
    BAM