Tag Archives: Medtronic
Do Vitamin Drinks Pose Health Risks?
Scientists are concerned vitamin drinks are contributing to levels of vitamins and other nutrients that are not only unnecessary, but potentially harmful.
FDA Urged to Ban Powdered Caffeine
Pennsylvania Senator Robert Casey has written to the Food and Drug Administration (FDA) to urge the agency to ban powdered caffeine, a dietary supplement.
New York Man Claims Biomet Metal-on-Metal Hip Implant Caused Pain, Disability
A New York man claims his metal-on-metal hip implant was defective and required replacement within a year of receiving it. This has left him facing a lifetime of pain, disability, and rising medical costs.
Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation
A vital food safety program was saved from budget cuts this week, enabling the country’s largest—although considered by experts to be far too small—produce-safety testing program to continue.
Pradaxa Associated with more Complications than Warfarin, According to Early Study Findings
Early results from the largest study to date to compare Pradaxa and warfarin indicate that in a real-world setting, Pradaxa causes more complications than decades-old warfarin. The preliminary study results were announced last week, during the 2012 Thrombosis and Hemostasis Summit of North America.
Stryker Issues Voluntary Recall for Rejuvenate Modular and ABG II Hip Implant Components
Stryker Orthopedics is recalling two metal-on-metal hip implant components, its Rejuvenate Modular and ABG II modular-neck hip stems. According to a notice posted on Stryker’s website, risks associated with the Rejuvenate Modular and ABG II modular-neck hip stems include the potential for fretting and/or corrosion at or about ...
Exposure to Common Pesticide May Increase ADHD Risk
A new study has found that exposure to a common household pesticide may increase the risk of attention deficit hyperactivity disorder (ADHD) in children.
Older Hip Implant, Knee Replacement Patients Face Heart Attack Risk Following Surgery
An emerging report reveals that older hip implant and knee replacement patients face increased heart attack risks following surgery. The risk for acute myocardial infarction (AMI) was seen in the first two weeks after these surgical procedures.
Bisphosphonate Study Confirms Atypical Thigh Fracture Risk
New research has confirmed the link between bisphoshonates, such as Fosamax, and atypical femur fractures, a type of thigh fracture that occurs spontaneously, without any major leg injury. The study, published in the Archives of Internal Medicine, also found that the risk of atypical thigh fractures increases the longer a ...
Actos Bladder Cancer Lawsuit Filed by West Virginia Resident
Actos (pioglitazone) continues to be named in lawsuits alleging long-term use of the type 2 diabetes drug caused patients to develop bladder cancer. Just last week, the national law firm of Parker Waichman LLP filed suit against Takeda Pharmaceuticals on behalf of a West Virginia man who developed bladder cancer ...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
HeartWare International Heart Pump Subject to FDA Class 1 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
Deep Brain Stimulation Rechargers May Fail to Charge, Medtronic Warns
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
Medtronic Recalls Thousands of 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
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
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
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
Medtronic Pays $500 Million Tax Charge To Move $9.8 Billion To United States
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
Newly Approved Medtronic 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
European Regulators Review Medtronic’s InductOs in Light of Contamination Issues
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
