Medtronic controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2021
HeartWare HVAD safety action
Medtronic recalled the HeartWare ventricular-assist system, and the FDA warned physicians to stop new implants because of increased risks of neurological adverse events and mortality associated with the internal pump.
2021
Medtronic recalls Valiant thoracic stent graft batches in Brazil over label errors
Recall announced
Medtronic voluntarily recalled specified batches of its Valiant Thoracic Stent Graft with the Captivia Delivery System in Brazil after Portuguese-language product labels were found to contain errors in the product name and registration number. The report says the issue did not affect product performance, no complaints or related patient injuries had been reported, and no follow-up corrective action was needed because the affected products were limited to Brazil.
Company response
Recall — 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。
Source excerpt
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。
2021
Medtronic recalls Pipeline Flex embolization devices
Recall announced
Medtronic recalled Pipeline Flex Embolization Devices after identifying a risk that delivery-system wires or tubes could fracture during device placement, retrieval, or movement. The article reports 59 malfunctions, 10 serious injuries, and two deaths related to the recall; the FDA identified it as a Class I recall.
Source excerpt
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.
2020
FDA recalls certain MiniMed 600 series insulin pumps
Recall announced
The FDA issued a Class I recall covering more than 322,000 Medtronic MiniMed 600 series insulin pumps because a defective retainer ring may cause insulin over- or under-delivery. The article reports more than 26,000 complaints, 2,175 injuries and one death related to the pumps.
Source excerpt
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.
2015
Tax-inversion controversy following Covidien transaction
The company's relocation of its legal and executive headquarters to Ireland after acquiring Covidien was criticized as a large U.S. corporate tax inversion. The transaction became a prominent example in public and policy debates about multinational tax structures.
2008
Kyphoplasty reimbursement settlement
Medtronic Spine agreed to pay $75 million to settle a qui tam action alleging that healthcare providers were encouraged to classify kyphoplasty as inpatient treatment to obtain higher Medicare reimbursement. The settlement resolved the allegations without the supplied material establishing a broader admission of wrongdoing.
2007
Sprint Fidelis lead recall
Medtronic recalled Sprint Fidelis defibrillator leads after failures were reported at an unacceptable rate. A failed lead could cause an inappropriate shock or prevent therapy when it was needed, creating serious clinical risk and litigation exposure.