The U.S. Food and Drug Administration (FDA) is looking at whether encephalitic brain inflammation is connected with Zinbryta, a multiple sclerosis (MS) drug marketed by AbbVie and Biogen. The FDA wants to know if encephalitis (brain inflammation) is a side effect of the drug. Encephalitis can lead to permanent brain injuries and fatalities. AbbVie and …
While many medical products are safe, there are times when situations occur that present a high level of concern for medical professionals and government regulators. Such is the case with the United States Food and Drug Administration (FDA), which recently chose to issue a Class 1 recall regarding 50 NeuroBlate brain probes. Designed to be …
Medical device recalls are common. Companies typically decide to recall a device when there is a health and safety issue. Here are some of the biggest medical device recalls in recent history: Abbott Pacemakers Recalled Because of Cyber-Security Issues Abbot announced that it would be recalling over 500,000 pacemakers in August 2017. They were recalled …
The FDA recently announced that medical device manufacturer Medtronic has issued an implantable cardioverter defibrillator recall for 48 of its resynchronization defibrillators. The reason for the recall is the device’s inability to deliver the correct level of voltage to effectively pace a person’s heartbeat. According to the American Heart Association, these devices are made to …
For many people who suffer from cardiovascular problems, relying on various heart devices to help their hearts work more efficiently is the difference between life and death. Because of this, many medical device manufacturers are investing millions of dollars into designing and manufacturing numerous devices to combat these and other problems. However, in some instances, …
Dream Body Weight Loss was a brand of diet pills that were common in some weight loss communities, but they are voluntarily recalling many of their products after concerns were raised over some of the ingredients in the pills. Though no customers have reported negative health effects yet, the company is choosing to recall the …
According to the United States Food and Drug Administration (FDA), there were almost 70 medical devices recalled over the past two years. In 2016, there have already been over 20 devices recalled, indicating that the epidemic of medical technology recalls is not slowing down. There are several reasons why medtech recalls seem to be an …
The FDA has issued a Class I recall for some of GE healthcare’s neonatal resuscitation devices after the company discovered life-threatening malfunctions. Giraffe Warmer and Panda Warmer Resuscitation systems were designed to resuscitate infants and newborns it was also used to regulate body temperature. However, on November 18th GE sent an urgent medical device correction …
Covidien, a global healthcare product manufacturer, has issued a recall for certain lots of its Pipeline Embolization Device and Alligator Retrieval Device. What Is The Covidien Pipeline Embolization Device and Alligator Retrieval Device? The Pipeline Embolization Device (PED) is the first and only flow diversion device approved by the FDA. The Pipeline Device is designed …
Nowadays it seems next to impossible to keep up with the number of items we see being recalled daily here in the United States. From toys to baby formula, vehicle parts, and medications; the list is overwhelming at times to know what is safe and what isn’t.