Worldwide Distribution -- USA, Austria, Denmark, Finland, France, Great Britain, Italy, Netherlands, and Sweden.
Descripción del producto
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.
“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.”
Worldwide Distribution -- USA, Austria, Denmark, Finland, France, Great Britain, Italy, Netherlands, and Sweden.
Descripción del producto
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.