Device Recall HydroThermAblator Endometrial Ablation System

  • Modèle / numéro de série
    Lot Numbers: 35421, 35422, 35423, 35424, 35425, 35426, 35846, 35847, 35890, 35891, 35892, 36038, 36039, 36040, 36041, 36042, 36047, 36048, 36104, 36105, 36141, 36142, 36143, 36146, 36147, 36148, 36214, 36215, 36234,36235, 36249, 36250, 36251, 36260, 36261 ,36370, 36371, 36372, 36467, 36468, 36682, 36683, 36684, 36685, 36686, 36688, 36689, 36690, 36693, 36694, 36695, 37049, 37098, 37099, 37149, 37150, 37151, 37154, 37192, 37218, 37219, 37220, 37221, 37222, 3and 7223.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Austria, Denmark, Finland, France, Great Britain, Italy, Netherlands, and Sweden.
  • Description du dispositif
    Boston Scientific HydroThermAblator Endometrial Ablation System- || HTA¿ System Procedure Set with Tenaculum Stabilizer and Disposable Heater Canister (5/bx) || Material/UPN/Catalog Number: M006560201 || System-HTA¿ System Procedure Set with Tenaculum Stabilizer and Disposable Heater Canister (ea) || Material/UPN/Catalog Number: M006560200 || Intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • 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
    USFDA

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  • Modèle / numéro de série
    Lot Numbers: 35773, 35854, 35855, 36070, 36071, 36072, 36073, 36259, 36462, 36463, 36852, 37046, 37047, 37432, and 37433.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Austria, Denmark, Finland, France, Great Britain, Italy, Netherlands, and Sweden.
  • Description du dispositif
    Boston Scientific HydroThermAblator Endometrial Ablation System- HTA¿ Procedure Set (5/bx) || Material/UPN/Catalog Number: M006550161 || Boston Scientific HydroThermAblator Endometrial Ablation System-HTA¿ Procedure Set (ea) || Material/UPN/Catalog Number: M006550160 || Intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete.
  • Manufacturer