美敦力的争议事件

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• 召回 — Medtronic Inc.

  生产商美敦力公司Medtronic Inc.对胸主动脉覆膜支架系统Valiant Thoracic Stent Graft with the Captivia Delivery System（注册证号：国械注进20143135591）主动召回。

来源摘录

• 因受影响产品仅涉及巴西，不涉及中国，故无需采取后续纠正行动。

• 日前，美敦力（上海）管理有限公司报告，由于涉及特定型号、特定批次产品葡萄牙文标签错误，生产商美敦力公司Medtronic Inc.对胸主动脉覆膜支架系统Valiant Thoracic Stent Graft with the Captivia Delivery System（注册证号：国械注进20143135591）主动召回。

• 该问题不会影响产品性能，未收到投诉，未发现本问题引起的患者伤害，从患者安全角度是没有危害的。

来源摘录

• The company said there is a risk of the delivery system’s wire and tubes fracturing and breaking off when the system is being used to place, retrieve, or move the stent inside a patient.

• A recall letter was sent to all customers July 13, 2021, requesting them to: • Stop use of any impacted product. • All unused impacted products should be immediately quarantined.

• September 21, 2021 — Medtronic is recalling its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology, which are transcatheter devices used to seal brain aneurysms.

来源摘录

• The defective pumps provide an “over or under-delivery of insulin, which could then result in hypoglycemia or hyperglycemia,” according to a letter Medtronic sent to customers in November.

• The Food and Drug Administration has issued a Class I recall, the most serious type of recall, on certain Medtronic MiniMed 600 series insulin pumps used by thousands of individuals with Type 1 diabetes.

• There have been over 26,000 complaints, 2,175 injuries and one death related to the insulin pumps, according to a statement released by the FDA.