Six of the Worst Medical Device Recalls of 2020

Technology produces some pretty amazing devices for the medical field that enhance treatment and recovery options. Companies that design these gadgets often rush their products to market by cutting corners such as using subpar materials or not testing as thoroughly as they should to ensure safety.

Streamlining medical treatment is big business, but patients shouldn’t have to pay for it by becoming injured or dying because of defective medical devices that result in medical malpractice. According to the Food and Drug Administration (FDA), this year has seen its fair share of medical product recalls. Below are six of the most dangerous that made the list.

Dangerous medical devices that were recalled in 2020

Each of the recalls discussed below are Class I with reported injuries and deaths. If you have had any medical complications after needing medical treatment that may have required use of any of the below devices, you may want to seek legal advice to determine whether you are the victim of medical malpractice.

1. Medtronic MiniMed insulin pumps. Beginning late last year and into 2020, two models of this insulin pump have been responsible for 2,175 injuries and one death. These pumps are used by children and adults diagnosed with Type I diabetes to deliver life-saving insulin. The pump design includes a retainer ring intended to hold the insulin cartridges in place, however it has either been broken or missing on many pumps. This causes too much or too little insulin to be delivered to the patient, which can cause hypoglycemia or hyperglycemia, which can be fatal.
2. Becton Dickinson CareFusion 303 Inc. Alaris system infusion pumps. In February, there were 774,000 units of this device recalled after experiencing software and system errors. The pump is responsible for monitoring vital signs while delivering controlled amounts of various fluids to the body intravenously, including medications. The software errors that have occurred pose a severe danger to patients whose infusions could be interrupted, delayed, slowed, or sped up. The end result may be a patient receiving too much or too little of the fluid or medication they require. When dealing with medication such as chemotherapy drugs, under-medicating or overmedicating someone can produce deadly consequences. To date there have been 55 injuries and one death reported from this defective medical device.
3. Stryker Neurovascular Trevo XP ProVue Retriever. Recalled in September after 11 reported injuries and one patient dying, the company instructed medical providers to pull 1,258 of these devices from circulation and return them to the company. The job of the retriever is to remove blood clots from the brain and restore blood flow after the patient has suffered an ischemic stroke. It was discovered that during use, the core wire could break or split apart as it is being removed. The result is that the wire could be left inside a blood vessel or tissue causing a series of complications including a blockage, disability, or death.
4. Medtronic StealthStation auto-registration feature. There have been 11 reported injuries related to the malfunctioning of this brain mapping software. The program is designed to automatically save the mapped-out path for inserting leads into the brain in order to assist the surgeon during the procedure. The software fails to consider slight movements of patients during the imaging phase, which can result in incorrect navigation of the pathway during the procedure. Even a slight wrong move while working in the brain can cause serious permanent damage to victims. This device was recalled in early August.
5. Medtronic Pipeline Flex embolization device. Recalled in February, there have been 10 injuries and one death attributed to this device’s defect. This device is a wire mesh cylinder stent put in place with a guide-wire system for the treatment of brain aneurisms. The guidewire is at risk for fracturing while placing the stent, leaving pieces inside the victim’s brain bloodstream. Attempting to remove any of the fractured pieces could cause further harm such as blocking of blood vessels, initiating a stroke, or causing death. These devices are supposed to have been removed from circulation to prevent further use.
6. Medtronic Rashkind balloon septostomy catheters. With two reported injuries and one death on record, this device was only recalled in August. The catheters are used in the treatment of patients with Cyanotic congenital heart defects. It was determined that the poor quality of the catheter could cause it to break, separate or fail, which could cause damage to blood vessels and death. The device is no longer being manufactured or delivered so if you determine that your doctor has recently used this catheter on you, he or she may be putting you at risk.

How the FDA classifies recalls

Depending upon the issue with a medical device, the FDA will categorize a recall under three classification levels. These levels signify the severity of the risk. Injury or death does not need to have already occurred for a device to earn a particular classification.

• Class I means that a reasonable probability exists that the device will in some way cause serious harm to the patient’s health or end in death.
• Class II generally means that the product could cause temporary or medically reversible health consequences, or that it’s unlikely but possible that the patient will experience those adverse health consequences.
• Class III is used when complaints have been made about a product but there is negligible risk of harm.

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