A Class I recall has been issued for Abbott’s HeartMate 3 left ventricular assist devices due to possible twisting and eventual occlusion of the outflow graft which can create a risk of serious injury or death.
According to Mass Device, the HeartMate 3 devices are being recalled due to a malfunction in the outlaw graft assembly. The defect could result in the outflow graft twisting and occluding over time, which could cause stalled pump flow and a persistent low flow alarm in the system.
Such a reduction in pumping can lead to serious adverse events, including blood clots and death.
In total, the recall affects 4,878 units across the U.S. Recall units will have catalog numbers of 106524US, 106524, or 10652INT. All defective devices were distributed after September 2, 2014.
When issuing recalls, the U.S. Food and Drug Administration will assign a classification designating how serious recall is and the potential adverse health outcomes posed by the recalled product, drug, or device.
The classifications are as follows:
A recall is terminated only after the FDA deems the product no longer in violation of the law and no longer presents a health hazard to patients.
Defective and faulty medical devices have the potential to cause long-lasting and permanent damage in patients seeking treatment for their injuries and illnesses. In some cases, defective medical devices have caused fatal injuries, causing devastation to the victim’s family. At Thomas J. Henry, we will fight vigorously on you and your family’s behalf. We have the legal and financial resources necessary to properly develop your case and take on the large pharmaceutical and medical device manufacturers.
If you or a loved one have been injured by a medical device, call us today — attorneys are available 24/7, nights and weekends. Our firm has offices in Corpus Christi, San Antonio, Austin, and Houston, serving clients across Texas and nationwide.