Tag Archives: Medtronic

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Johnson & Johnson Marketing of Gynecare Prolift Transvaginal Mesh Raises More Questions

Johnson & Johnson and its Ethicon unit are again coming under scrutiny for the way it marketed its Gynecare ProLift transvaginal mesh product. According to a new report from Bloomberg News, Johnson & Johnson continued marketing the Gynecare ProLift device for months after it received a warning from the ...

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FDA Warning for Bone Graft Products in Patients Under 18

FDA Safety Warning for Bone Graft Products in Patients Under 18

FDA issued safety alerts to patients, parents & guardians, bone graft devices w/recombinant proteins or synthetic peptides not to be the first treatment for 18 & under.

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Study Suggests Hormonal Contraceptives Linked to Brain Tumor

Study Suggests Hormonal Contraceptives Linked to Increased Brain Tumor Risk

A study of Danish women of reproductive age suggests that long-term use of hormonal contraceptives is associated with an increased risk of brain tumors.

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Estate of Kentucky Man Alleges Wrongful Death Due to Actos Bladder Cancer

National law firm, Parker Waichman LLP, just filed a lawsuit on behalf of the estate of a Kentucky man who developed bladder cancer and subsequently died, allegedly due to the use of diabetes drug, Actos. The lawsuit names Takeda Pharmaceuticals America, Inc., Takeda Pharmaceuticals USA, Inc., Takeda Pharmaceuticals North America, ...

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Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery

DePuy Orthopaedics and its parent, Johnson & Johnson, continue to be named in lawsuits by metal-on-metal hip replacement recipients who suffered severe injuries, including elevated chromium and cobalt levels, allegedly due to recalled ASR hip implant devices. Most recently, the national law firm of Parker Waichman LLP filed suit on ...

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Actos, Avandia May Up Risk for Diabetic Macular Edema

A West Virginia man fitted with a metal-on-metal version of DePuy Orthopaedics’ Pinnacle Hip Implant System has filed suit against the company and its parent, Johnson & Johnson, alleging the device caused him to suffer pain and elevated cobalt levels. The Plaintiff is being represented by the national law ...

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What Action Will the FDA Take on E-cigarettes?

What Action Will the FDA Take on E-cigarettes?

As health and quality concerns trouble the e-cigarette industry, experts and the public await the Food and Drug Administration (FDA)’s action to regulate the devices.

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Canadian Warning Issued for Actos Bladder Cancer Side Effect Risk

Health Canada has become the most recent national drug regulator to issue a warning about Actos and bladder cancer. Last month, the agency warned that interim results from a 10-year-study indicated that patients taking Actos for more than a year faced an increased risk of bladder cancer. Health Canada also ...

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Catheter Recalls due to Serious Complications and Injuries

Catheter Recalls due to Serious Complications and Injuries

The benefits and usefulness of catheters are not in question, when the broad scope of applications and indications for which the devices are used are examined. Catheters are used for administering medications, injecting contrast dye for angiogram procedures, and removing … Continue reading

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HeartWare International Heart Pump Subject to FDA Class 1 Recall

HeartWare International Heart Pump Subject to FDA Recall

Medtronic has announced that the U.S. Food and Drug Administration (FDA) has classified two global voluntary recalls of HeartWare International’s HeartWare Ventricular Assist Device (HVAD) as Class 1 recalls. A class 1 recall is the FDA’s most serious recall category, … Continue reading

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Deep Brain Stimulation Rechargers May Fail to Charge, Medtronic Warns

Deep Brain Stimulation Rechargers May Fail to Charge

In an October 2016 “Urgent Field Safety Notice”, Medtronic warned that some rechargers for its deep brain stimulation devices may be prone to an “error state” and fail to charge. According to the letter, some of its Model 37751 rechargers … Continue reading

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Medtronic Recalls Thousands of Lots of Various Neurovascular Products

Medtronic Recalls Lots of Various Neurovascular Products

Medtronic PLC just recalled certain lots of four of its neurovascular products. The device maker noted that the recalled devices might lead to a thromboembolic event (blood clot) in patients. The recalled Medtronic neurovascular products are: Pipeline Embolization Device (1742 … Continue reading

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Medtronic Recalls Temporary Cardiac Lead Pacing Systems

Medtronic Recalls Temporary Cardiac Lead Pacing Systems

The Food and Drug Administration (FDA) has announced a Class II designation for a recall involving thousands of Medtronic temporary lead pacing systems because there is the potential for them to connect to a hazardous voltage. The recall involves 11,697 of … Continue reading

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Medtronic Issues Warning for Heart Valve Delivery System

Medtronic Issues Warning for Heart Valve Delivery System

Medtronic PLC has issued a warning regarding its minimally invasive EnVeo R delivery system, which is used to implant the Evolut R aortic valve in the heart. The company is urging doctors to take extra precautions when inserting the device, … Continue reading

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Medtronic Uses Preemption in Medtronic Infuse Case, Again

Medtronic Uses Preemption in Medtronic Infuse Case, Again

The denial of review by the United States Supreme Court today in the case of Caplinger v. Medtronic, Inc., Docket No. 15-321, though it might appear to be a victory for medical device manufacturer, Medtronic, Inc., it was not. While … Continue reading

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Medtronic Pays $500 Million Tax Charge To Move $9.8 Billion To United States

Medtronic Pays $500M Tax Charge To Move $9.8B To U.S.

As part of an internal restructuring related to its $49.9 billion merger with Covidien, Medtronic will pay a one-time tax charge of $500 million so that it can bring $9.8 billion in overseas cash to the United States. This move … Continue reading

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Newly Approved Medtronic Heart Device Component Under Recall

Medtronic's Heart Device Component Under Recall

Just weeks after receiving Food and Drug Administration (FDA) approval, Medtronic’s EnVeo R Loading System, used with the CoreValve Evolut R system for transcatheter aortic valve replacement (TAVR), has been recalled. Medtronic said it had received eight reports of the … Continue reading

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European Regulators Review Medtronic’s InductOs in Light of Contamination Issues

European Regulators Review Medtronic’s InductOs

The European Medicines Agency (EMA) will be reviewing Medtronic’s InductOs following reports of contamination problems at a site that manufacturers one of the product’s components. InductOs is an implantable bone development product used in patients undergoing spinal fusion in the … Continue reading

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