The Deadly Medical Devices That Were Recalled In 2020

The FDA publishes a public list of the devices that have been recalled for safety. In 2020 there were 23 devices that were recalled. If you or a loved one had a medical procedure using one of these devices and there were significant complications leading to a serious injury or death, you should contact an attorney that specializes in medical malpractice. See the chart at the bottom of this article for the full list of products recalled in 2020 by the FDA.

The following products resulted in patient deaths:

Trevo XP ProVue Retriever

Device type: The device is intended to restore blood flow or remove blood clots within a blood vessel in the brain during an acute ischemic stroke.

Reason for Recall: There is a risk the core wire may break or separate during use, causing the device to be left inside the patient’s blood vessel or tissue. This could cause bleeding, additional blockage of blood vessels, disability, and death.

The Rashkind Balloon Septostomy Catheters

Device type: The catheters are used to create an atrial septal defect or to enlarge an existing atrial septal defect as a treatment option for patients with Cyanotic Congenital heart defects.

Reason for Recall: Device quality issues that may lead to the device breaking, separating or failing during use, which may cause serious damage to blood vessels (vascular injury) and death.

Alaris System Infusion Pumps

Device Type: An infusion pump and vital signs monitoring system. The system is used in adult, pediatric and neonatal care.

Reason for Recall: Various mechanical and hardware failures that can lead to injuries and death.

The Pipeline Flex Embolization Device (“Pipeline Flex”)

Device Type: A permanent mesh cylinder (stent) intended for the treatment of brain aneurysms that bulge or balloon out the sides of the blood vessel (wide-neck and fusiform). It also includes the delivery system.

Reason for Recall: There is a risk the delivery system could fracture while placing the stent inside the patient. The remaining pieces or the attempts made to retrieve them can make the condition worse or can cause other problems, such as continued blockage of blood vessels, stroke, and death.

The NC TREK RX Coronary Dilatation Catheter

Device type: Coronary dilation catheters are used to open clogged blood vessels to improve blood flow to the heart.

Reason for Recall: The balloons from the impacted lots may not deflate as intended, which can cause serious adverse health consequences, such as prolonged cardiac ischemia (reduced blood flow to the heart), air embolism, thrombosis (clot in the artery), myocardial infarction (heart attack), and additional surgery that could lead to postoperative complications, including death.

Stellar 100 and 150 Non-invasive and Invasive Ventilators

Device Type: Non-invasive (air pushed through a mask or mouthpiece) and invasive (air pushed through a tube into the windpipe) ventilators are used to provide breathing support to adult and pediatric patients who are non-ventilator dependent and spontaneously breathing.

Reason for Recall: The sound alarm may fail to work, which can lead to serious injury or death.

MiniMed Insulin Pumps

Device Type: For people with Type 1 diabetes the insulin pump is intended to deliver insulin for the management of diabetes.

Reason for Recall: A missing or broken retainer ring which helps to lock the insulin cartridge can result in under or over delivery of insulin, which could result in a loss of consciousness, seizure, and death.

Many more devices resulted in injuries or presented dangers that could lead to serious injury or death. This chart shows the complete list as of May 20, 2021. If you suspect you or your loved one was injured as a result of using one of these products, it would be wise to contact an attorney that specializes in medical malpractice.