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Abbott Recalls Malfunctioning Coronary Catheters That May Lead to Surgical Complications and Death

By The Burg Simpson Ohio Team

On May 16, 2017 the U.S. Food and Drug Administration (FDA) announced that several lots of cardiac catheters manufactured by Abbott needed to be recalled due to the significant risk that the affected catheters may malfunction, possibly causing surgical complications and even death. FDA Safety Alert Announcement The affected lines of catheters include the NC… Read more »

Medtronic Recalls StrataMR Adjustable Valves and Shunts Which May Cause Fluid Buildup in the Brain

By The Burg Simpson Ohio Team

On April 19. 2017 the U.S. Food and Drug Administration (FDA) announced that Medtronic initiated an urgent recall of its StrataMR adjustable valve and shunt devices. Because of the risk that these medical devices will cause significant adverse health consequences or death, the FDA has identified this as a Class I recall, which is the… Read more »

FDA Announces Recall of Hyland’s Homeopathic Teething Tablets

By The Burg Simpson Ohio Team

On April 13, 2017 the U.S. Food and Drug Administration (“FDA”) announced the recall of all lots of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets by the manufacturer, Standard Homeopathic Company. This recall follows the FDA’s September 2016 warning against the use of homeopathic teething products. At that time the FDA stated… Read more »

Zimmer Biomet Recalls Shoulder Device Due To High Fracture Rates

By The Burg Simpson Ohio Team

On December 20, 2016 Zimmer Biomet issued a recall of its Comprehensive Reverse Shoulder replacement system.  The Zimmer Reverse Shoulder system is a shoulder replacement device that is surgically implanted to help restore arm movement for those patients with rotator cuff tears who have developed severe shoulder arthritis (i.e., arthropathy).  Zimmer issued the recall because… Read more »

High Fracture Rates Lead to Recall of Zimmer Biomet Comprehensive Reverse Shoulder

By The Burg Simpson Ohio Team

Zimmer Biomet has initiated an urgent recall of its Comprehensive Reverse Shoulder due to high fracture rates.  While this shoulder replacement device is intended to help restore arm movement, the FDA indicates that when the Comprehensive Reverse Shoulder fractures, individuals may require “revision surgeries which could cause serious adverse health consequences such as permanent loss… Read more »

Dangerous Ingredient in Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplements Leads to Recall

By The Burg Simpson Ohio Team

On February 7, 2017, Kingsway Trading Inc. issued a recall of Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement because it contains an ingredient, Ephedra Herba (ma huang), that was not disclosed in the supplement’s ingredients list and that has been banned by FDA. Bi Yan Pian, sometimes called “Nose Inflammation Pills,” are often… Read more »

Recall of Multiple Medtronic Neurovascular Products

By Burg Simpson

On December 1, 2016 the U.S. Food and Drug Administration identified a Class I recall of several Medtronic Neurovascular products. Class I recalls are the most serious type of recall, issued only when the FDA finds a reasonable probability that use of the product will cause serious adverse health consequences or death. The devices included… Read more »

Hyoscyamine Tablets Recalled Because of Potency Concerns

By Burg Simpson

The United States Food and Drug Administration (“FDA”) has issued an announcement stating that Virtus Pharmaceuticals Opco II, LLC (“Virtus”) is voluntarily recalling seven batches of Hyoscyamine sulfate manufactured by Pharmatech LLC.  This recall was initiated because test results indicated that certain batches of the drug were either superpotent or subpotent.  In other words, certain… Read more »

FDA Warns Surgeons Three Deaths are Potentially Related to Vascu-Guard Patch

By Burg Simpson

The United States Food and Drug Administration (“FDA”) has issued a letter to surgeons warning them about three deaths “potentially” related to Baxter International Incorporated’s Vascu-Guard Peripheral Vascular Patch.  The FDA cautioned surgeons in this letter that the Vascu-Guard patch may not be performing as intended during carotid endarterectomy (“CEA”) procedures, leading to serious adverse… Read more »

Recall of Arrow International Intra-Aortic Balloon Catheters

By Burg Simpson

Medical Device Safety and Recalls: Arrow International Inc. Recalls Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits Due to Sheath Separation Issue On March 17, 2016 the U.S. Food and Drug Administration (FDA) identified a Class I recall of Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits. These balloon catheters are implanted into… Read more »

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