TELIGEN implantable cardioverter defibrillators (ICD) and COGNIS cardiac resynchronisation therapy devices (CRT-D)

  • Modelo / Serial
  • Descripción del producto
    TELIGENTM implantable cardioverter defibrillators (ICD) and COGNISTM cardiac resynchronisation therapy devices (CRT-D) manufactured by Boston Scientific.The manufacturer has issued a Field Safety Notice (400Kb) (FSN) in relation to the second subset of affected devices. This notice has been distributed to clinics that have implanted these devices and conduct routine patient follow-up, and also to clinics equipped with compatible programmers.Device family   Affected model numbers COGNIS CRT-D   N106/N107/N118/N119/P106/P107/P108 TELIGEN DR ICD   E110/F110/F111 TELIGEN VR ICD   E102/F102/F103You can check specific device–serial number combinations to find out if they are affected. This look-up tool differentiates newly identified devices from those already subject to the 2013 advisory notice.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Lisa Austin Boston Scientific Breakspear Park Breakspear Way Hemel Hemsptead, HP2 4TZ Tel:    01442 411 600Email:
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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.”
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