Devices

Device Recall WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM

  • 모델명 / 제조번호(시리얼번호)
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  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution.
  • 제품 설명
    Boston Scientific, WALLGRAFT¿¿ OVER-THE-WIRE, Tracheobronchial Endoprosthesis, Made in IRELAND, Ballybrit Business Park, Galway, IRELAND, STERILE, EO. || The WALLGRAFT Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms. || Material Catalog # Description || M001705020 70-502 WALLGRAFT PKG T/B/10X20 10FR COMML || M001705030 70-503 WALLGRAFT PKG T/B/10X30 10FR COMML || M001705050 70-505 WALLGRAFT PKG T/B/10X50 10FR COMML || M001705070 70-507 WALLGRAFT PKG T/B/10X70 10FR COMML || M001705230 70-523 WALLGRAFT PKG T/B/12X30 11FR COMML || M001705250 70-525 WALLGRAFT PKG T/B/12X50 11FR COMML || M001705270 70-527 WALLGRAFT PKG T/B/12X70 11FR COMML || M001705450 70-545 WALLGRAFT PKG T/B 14X50 12 FR || M001705470 70-547 WALLGRAFT PKG T/B 14X70 12FR || M001705620 70-562 WALLGRAFT PKG T/B/6X20 9FR COMML || M001705630 70-563 WALLGRAFT PKG T/B/6X30 9FR COMML || M001705650 70-565 WALLGRAFT PKG T/B/6X50 9FR COMML || M001705670 70-567 WALLGRAFT PKG T/B/6X70 9FR COMML || M001705720 70-572 WALLGRAFT PKG T/B/7X20 9FR COMML || M001705730 70-573 WALLGRAFT PKG T/B/7X30 9FR COMML || M001705750 70-575 WALLGRAFT PKG T/B/7X50 9FR COMML || M001705770 70-577 WALLGRAFT PKG T/B/7X70 9FR COMML || M001705820 70-582 WALLGRAFT PKG T/B/8X20 9FR COMML || M001705830 70-583 WALLGRAFT PKG T/B/8X30 9FR COMML || M001705850 70-585 WALLGRAFT PKG T/B/8X50 9FR COMML || M001705870 70-587 WALLGRAFT PKG T/B/8X70 9FR COMML || M001705920 70-592 WALLGRAFT PKG T/B/9X20 10FR COMML || M001705930 70-593 WALLGRAFT PKG T/B/9X30 10FR COMML || M001705950 70-595 WALLGRAFT PKG T/B/9X50 10FR COMML || M001705970 70-597 WALLGRAFT PKG T/B/9X70 10FR COMML
  • Manufacturer
    Boston Scientific Corporation
  • 1 Event

제조사

Boston Scientific Corporation
  • 제조사 주소
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • 제조사 모회사 (2017)
    Boston Scientific
  • 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
    USFDA