Boston Scientific, one of the world’s largest manufacturers of medical devices, is recalling its INGENIO family of pacemakers and CRT-Ps due to the risk of serious adverse health consequences. The U.S. Food and Drug Administration has identified this as a Class 1 recall, indicating that the use of these devices may cause serious injuries or death.
Boston Scientific has received reports associated with its INGENIO pacemakers in which devices incorrectly transition to Safety Mode. Boston Scientific has determined that this error is linked to a battery condition which puts the device at risk for system resets. If three system resets occur within a 48-hour period, the device is designed to immediately enter Safety Mode, at which point a replacement is required. Boston Scientific has published a list of affected products.
According to the FDA, there have been 65 reported incidents. Fortunately, no deaths have been reported. However, the FDA is warning that the use of affected products may cause serious adverse health consequences, including worsening of heart failure and death.
Dangerous or defective medical devices can give rise to a product liability claim. Medical devices improve the lives of hundreds of thousands of Texans, but when those devices do more harm than good it may be time to contact a lawyer. You may be entitled to compensation for the bills and lost wages as well as the damages resulting from injuries caused by your medical implant.
If you or someone you love has been injured as the result of a defective product, contact an experienced attorney at Abraham, Watkins, Nichols, Agosto, Aziz & Stogner by calling at 713-742-6008 or 888-229-5094 for your free consultation. The law firm of Abraham, Watkins, Nichols, Agosto, Aziz & Stogner is the longest-standing personal injury firm in Texas, and our attorneys are standing by to assist with your claim.