LotusTM Valve System

Fabricant

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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
    AEMPSVFOI

5 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Catalog Number: viz seznam soucasti FSN LTV23 LTV25 LTV27 Model Number: viz seznam soucasti FSN H749LTV230 H749LTV250 H749LTV270
  • Description du dispositif
    Inactive implantable medical devices
  • Manufacturer
  • Modèle / numéro de série
    Catalog Number: LTV23 LTV25 LTV27 Model Number: H749LTV230 H749LTV250 H749LTV270 Batch Number: All, as indicated in the Field Safety Notice
  • Description du dispositif
    Inactive implantable medical devices
  • Manufacturer
  • Modèle / numéro de série
    all
  • Description du dispositif
    MD: Transcatheter heart valve bioprosthesis, stent-like framework
  • Manufacturer