watchman flx

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “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
    MSHM

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  • 모델명 / 제조번호(시리얼번호)
    WS5020 18225672, 18225673, 18225674, 18396812, 18401612, 18459184, 18581834, 18603231, 18682283, 18688431, 18688432, 18707084, 18736313, 18751534, 18751536, 18838165, 18845130, 18875658, 18900177, 18914801, 18914802, 18929298 WS5024 18396813, 18401613, 18408201, 18408202, 18435076, 18480472, 18492730, 18581835, 18591486, 18603232, 18682284, 18682288, 18688428, 18707085, 18736314, 18742868, 18751537, 18838166, 18866426, 18900176, 18914803, 18915361, 18934783, 18944586, 18972521, 18979870 WS5027 18396814, 18408203, 18409435, 18435077, 18459185, 18492731, 18581836, 18591490, 18682285, 18682289, 18707086, 18736315, 18751538, 18751539, 18838167, 18866427, 18876065, 18908883, 18914808, 18914809, 18914810, 18914811, 18914812, 18929299, 18934786, 18944584, 18944587, 18972522, 18979879, 18989184 WS5031 18396811, 18408205, 18435078, 18459186, 18534734, 18581837, 18591358, 18682286, 18707087, 18736316, 18752110, 18832856, 18845134, 18876063, 18893436, 18914813, 18934784, 18944588, 18980043, 18989186 WS5035 18182797, 18225668, 18225671, 18401059, 18435079, 18483583, 18581838, 18682287, 18707088, 18736317, 18751760, 18832857, 18845135, 18876066, 18900178, 18914814, 18934785
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Boston Scientific WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Devices with Delivery System
  • Manufacturer
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