Device Recall AngioJet SOLENT Omni Thrombectomy Set

  • 모델명 / 제조번호(시리얼번호)
    162185 162318
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN.
  • 제품 설명
    AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.
  • Manufacturer
  • 1 Event

제조사

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