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Ohio Dangerous Drugs and Medical Devices

Cook Medical Recalls Fixed Core Wire Guides

By Burg Simpson

Cook Medical is recalling one lot of its Fixed Core Wire Guides because it was dropped during production. A Fixed Core Wire Guide is a small wire device that is used to insert and guide other devices, such as a catheter, into and through a patient’s vein or artery. According to the recall notice, the… Read more »

Stryker Neurovascular Recalls Device Used to Treat Ischemic Stroke: Trevo XP ProVue Retriever

By Burg Simpson

Following 11 reports of injury, including one death, Stryker Neurovascular is recalling its Trevo XP ProVue Retriever. According to the recall, this device is intended to be used in treating an acute ischemic stroke. An acute ischemic stroke is caused when the blood flow through a blood vessel (i.e., an artery, vein, or capillary) in… Read more »

Birth Defects Associated With Medications To Treat Sleep Disorders

By Burg Simpson

A recent article published in the Journal of the American Medical Association (JAMA) reports findings from a pregnancy registry linking birth defects with the use of prescription drugs Provigil and Nuvigil. Provigil (generic Modafinil) and Nuvigil (generic Armodafinil) are approved by the FDA to treat excessive sleepiness in adults suffering from narcolepsy, sleep apnea, and… Read more »

Stent Lawsuits and Endologix, Inc.’s Recent Bankruptcy Filings

By Burg Simpson

Endologix bankruptcy

On July 5, 2020, Endologix, Inc. filed for bankruptcy and will seek to reorganize. By law, this bankruptcy filing pauses legal proceedings against Endologix, including many stent lawsuits filed by Burg Simpson regarding Endologix’s recalled AFX AAA device. Despite this pause, those that have been injured by a defective Endologix stent should not wait to… Read more »

Elmiron Warnings Changed to Include Risk of Eye Damage

By Burg Simpson

retinal scan

On June 16, 2020, significant new warnings were added to the label for Elmiron – a drug used to treat bladder pain and discomfort from a condition known as interstitial cystitis. For the first time, drug manufacturer Janssen Pharmaceuticals, Inc. warned that “[p]igmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been… Read more »

Endologix Recalls Ovation iX Abdominal Stent Graft System Due to Polymer Leaks

By Burg Simpson

aorta

On June 16, 2020 the FDA issued a Class I recall notice for the Ovation iX Abdominal Stent Graft System sold by Endologix, Inc. The Ovation iX device is used to treat patients with an abdominal aortic aneurysm (commonly called a “Triple A” or “AAA”). An AAA occurs when a patient’s aorta becomes stretched and… Read more »

Medtronic HeartWare Heart Pump Devices Recalled Due to Leaking

By Burg Simpson

stehoscope

On May 28, 2020 the U.S. Food and Drug Administration (FDA) issued a Class I recall notice concerning the Medtronic HeartWare Ventricular Assist Device (HVAD) System. A Class I recall is the FDA’s most serious designation and is used only for products that pose a reasonable probability of severe injuries or death. The Medtronic HVAD… Read more »

Drug Used to Treat Hypothyroidism Recalled Due to Super Potency

By Burg Simpson

prescription tablets

Acella Pharmaceuticals is recalling 13 lots of NP Thyroid ® – a drug used to treat hypothyroidism – for being “super potent.” According to the recall announcement posted by the U.S. Food and Drug Administration (FDA), the affected lots of NP Thyroid ® contain up to 115 percent of one of the drug’s active ingredients…. Read more »

Hair Loss Drug Recalled Due to the Presence of a Potentially Dangerous Ingredient

By Burg Simpson

hair loss drug

After discovering the drug for male pattern baldness contained a potentially dangerous ingredient not listed on its label, MasterPharm, LLC. is recalling 1 lot of  Finasteride Plus 1.25mg. The affected lot of Finasteride Plus was found to contain minoxidil. Minoxidil is a drug used to treat high blood pressure. According to the recall notice posted… Read more »

Vascular Solutions, Inc. Recalls Catheter due to Risk of Injury

By Burg Simpson

catheter

Vascular Solutions, Inc. has recalled Langston Dual Lumen Catheters distributed between July 12, 2019 and March 10, 2020 following eight reports that the catheter separated during use. What is the Langston Dual Lumen Catheter used for? The Langston Dual Lumen Catheter is used both to measure blood pressure within a blood vessel and to deliver… Read more »

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