Five products affected by the Field Action. 1. PIPELINE EMBOLIZING DEVICE - Registration 10349000471 - Technical Name: ANEURISMA IMPLANT - Risk Class IV ;. 2. ALLIGATOR RECOVERY DEVICE - Registration 10349000457 - Technical Name: DEVICES - Risk Class IV ;. 3. HYDROFILIC GUIDE X-CELERATOR - Registration 10349000313 - Technical Name: FIO CARDIOVASCULAR GUIDE - Risk Class II ;. 4. ULTRAFLOW HPC FLOW ORIENTED MICROCATETER - Record 10349000461 - Technical Name: INTRAVASCULAR MICROPHYDRUS CATETER - Risk Class IV ;. 5. MARATHON MICRO CATHETER FLOW DIRECTED - Record 10349000478 - Technical Name: INTRAVASCULAR MICROPHEPER CATHETER - Risk Class IV ;. Affected lots: Products manufactured between August 2014 and September 2016

Fabricante

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
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