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Medtronic 68 articles

Medtronic updates heart device software to address cybersecurity risks

Medtronic is notifying health care professionals and patients that some of its cardiac implantable electrophysiology devices (CIEDs) used to treat patients with heart failure or heart rhythm problems may pose a safety risk caused by cybersecurity vulnerabilities. The company will implement a network update to address the issue. The issue involves Medtronic CareLink and CareLink Encore Programmers, models 2029 and 29901, which are used during implantation and regular follow-up visits for Medtronic CIEDs, including pacemakers that provide pacing for slow heart rhythms, implantable defibrillators that provide an electrical shock or pacing to stop dangerously fast heart rhythms, cardiac resynchronization devices ... Read More

MedTronic heart device recalled due to electrical error

Medtronic is recalling more than 200,000 HeartWare Ventricular Assist Devices (HVAD systems) due to an electrical issue that could cause the device to disconnect from its electrical source, causing the pump to stop. This issue could cause patient harm such as exacerbation of heart failure symptoms, or symptoms such as mild weakness, dizziness, anxiety, nausea, loss of consciousness, or death. This recall is classified as a Class I recall, which is the most serious type of recall. Class I recalls are issued when use of a medical device may cause serious adverse events or death. The recall affects certain models ... Read More

Medtronic recalls revascularization device due to defect

Medtronic is recalling the MindFrame Capture LP revascularization device used to during procedures to treat strokes because the delivery wire may break or separate during use, leaving the clot retriever inside the patient’s bloodstream. This, or the attempts made to retrieve the device, can lead to further complications including bleeding, additional blockage of blood vessels, more severe stroke symptoms, or death. The MindFrame Capture LP revascularization device used to restore blood flow or remove blood clots within in a blood vessel in the brain during an acute ischemic stoke in patients ineligible for or who fail intravenous plasminogen activator (IV ... Read More

Medtronic recalls some implantable heart defibrillators

Medical device company Medtronic is recalling certain Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) due to a defect in the manufacturing process that causes an out-of-specification gas mixture inside the device, which may prevent it from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest. A delay or inability to deliver a shock in these cases could result in serious injury and/or death. ICDs and CRT-Ds are medical devices that provide pacing for slow heart rhythms, and electrical shock or pace to stop dangerously fast heart rhythms. Both ICDs and ... Read More

Medtronic recalls MiniMed infusion sets

Medtronic is recalling specific lots of MiniMed infusion sets used with all models of Medtronic insulin pumps because the vent membrane in affected sets can become blocked with fluid during the priming/fill-tubing process. This can lead to a potential over-delivery of insulin shortly after an infusion set change, which could cause hypoglycemia, or high blood sugar. Infusion sets affected by the recall hit the market in April 2017 and include a design update of the component the company believes is casing the over-delivery of insulin after an infusion set is changed. Medtronic recommends that customers only use infusion sets made ... Read More

Medtronic heart pump controller recall expanded

Medtronic Mechanical Circulatory Support, formerly known as HeartWare Inc., is expanding its recall of its HeartWare Ventricular Assist Devices (HVAD) heart pump controllers to include additional product code and instructions to exchanged recalled products. The HVAD controllers were recalled due to a loose power connector, which may cause the rear portion of the pump’s driveline connector to become separated from the front portion of the driveline connector. A loose connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures. If the speaker volume is decreased, the patient may not hear the alarm. ... Read More

Medtronic recalls defective ventilators

Newport Medical Instruments Inc., now a part of Medtronic, is recalling its Newport HT70 and Newport HT70 Plus ventilators because of a software issue that may cause the device to shut down unexpectedly without the alarm. If the ventilator shuts down, the patient may not receive enough oxygen and could suffer serious adverse health consequences such as brain damage or even death. The Food and Drug Administration (FDA) has classified this as a Class I recall, the most serious type of recall, because use of these devices may cause serious injuries or death. The Newport Ht70 and HT70 Plus ventilators ... Read More

Patient deaths prompt Medtronic warning

Two patient deaths and dozens of serious injuries have been linked to the use of non-Medtronic instruments with Medtronic’s NavLock Tracker used during spinal fusion and interbody procedures. As a result, the Food and Drug Administration (FDA) has issued a Safety Alert informing health care professionals that Medtronic would be updating its product labeling to clarify the use of non-Medtronic instruments with its NavLock Tracker. Medtronic’s updated communication involves the “Instructions for Use” and “Warnings” statements on the labeling of the device. The new “Indications for Use” section will be updated to inform surgeons that “the NavLock Trackers are intended ... Read More

Medtronic heart device recalled due to safety issues

The Food and Drug Administration (FDA) has classified Medtronic’s recent voluntary field action related to its ventricular assist device, HVAD System Controllers and DC Adapters as a Class I recall, the most serious type of recall involving products in which there is a reasonable probability that use or exposure to a violative product will cause serious adverse health consequences or death. A ventricular assist device is a mechanical pump used to increase the amount of blood that flows through the body when the heart’s natural ventricles does not perform well. The device is used to treat advanced heart failure. Medtronic ... Read More

Medtronic recalls valves, shunts due to design defect

Medtronic is recalling the StrataMR Adjustable Valves and Shunts due to a design problem. The Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall because use of these devices may cause serious injuries or death. Medtronic StrataMR adjustable valves and shunts are used to manage hydrocephalus, excessive accumulation of cerebrospinal fluid surrounding the brain and spinal cord. The device provides continuous cerebrospinal fluid flow from the ventricles of the brain into the right atrium of the heart or peritoneal cavity. The design allows the health care provider to non-invasively adjust ... Read More