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Medtronic Insulin Pump Recalled Following Patient’s Death

The U.S. Food and Drug Administration (FDA) issued a Class I recall – it’s most serious such classification – of Medtronic’s MiniMed 600 Series insulin pump following the death of one patient and at least 2,175 injuries. The Medtronic pumps being recalled include the MiniMed 630G (all lots before October 2019) and the MiniMed 670G (all lots before August 2019) after the FDA received more than 26,421 complaints about the models. In fact, Medtronic’s MiniMed 600 Series insulin pump is delivering the incorrect insulin dosage to patients due to a faulty retainer ring, which is missing on some MiniMed 600 series entirely.

The FDA warns that if the insulin cartridge is not locked firmly into place, the over or under-delivery of insulin could occur. Giving the incorrect amount of insulin to a patient could result in serious conditions, such as hypoglycemia or hyperglycemia, which usually involve a patient suffering loss of consciousness, seizures, or even death.

This only one of the multiple Class I recalls initiated regarding Medtronic insulin devices. In 2019, the FDA recalled Medtronic’s MiniMed Model 500 and 503 Remote Controllers due to cybersecurity threats in which third-parties could hack into the controller and record and replay the wireless communication between the remote and the MiniMed insulin pump. This could potentially result in the unauthorized third-party user instructing the device to either over-deliver or stop delivering insulin to a patient, leading to diabetic ketoacidosis or death.

Protecting Public Health Interest

On average, around 4,500 drugs and devices are pulled from circulation in the United States annually. While there may be thousands of products deemed unsafe for consumer use by the FDA, the majority of consumers will likely remain unaware of any present danger due to lack of notice from manufacturers and other affiliated companies. The FDA regulates the products listed below, which can be subject to recall should they violate the law:

• Pharmaceutical drugs
• Medical devices
• Vaccinations
• Blood and blood products
• Radiation-emitting products
• Transplantable human tissue

Given the critical, life-saving nature of many of the products the FDA regulates, it is of extreme importance that manufacturers and distributors be held accountable for product safety. This means sellers and manufacturers will need to work harder to alert consumers and remove harmful products from circulation before lives are critically altered or lost due to corporate negligence.

Recall Classifications

A Class I recall is the most serious type of product recall the FDA can issue. It signals that the item being recalled could cause serious injuries or death to consumers. The public deserves to be protected against harmful devices or drugs and manufacturers and distributors of such drugs and devices should be held accountable. The FDA assigns three different types of recalls based on the level of health hazard:

• Class I – there is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.
• Class II – use of or exposure to the product may cause temporary or medically reversible adverse health consequences and the probability of serious adverse health consequences is remote.
• Class III – use of or exposure to the product is not likely to cause adverse health consequences.

Consumers’ Rights

As was the case with the Medtronic recalls, many consumer complaints led to product investigations that uncovered harmful defects, some being as severe as Class I. Unfortunately, many companies only recall products after the FDA or the Centers for Disease Control (CDC) raise concerns. When consumers speak up against products that have caused them pain or harm, they are also protecting other consumers from the same damages.

Products Liability Attorneys

Consumers who use insulin pumps and other medical device products quite literally put their lives in the hands of medical device manufacturers. Consumer must be able to trust the safety of their medical products because when they fail, the price consumers and their loved ones pay is unfathomable. If you or a loved one was seriously injured or killed due to a medical device defect, the experienced trial lawyers at Whitfield Bryson LLP can discuss your legal options. Call us today at 855-926-2889 to schedule a free consultation.