When using any sort of medical device, users rightfully expect the device to work properly and provide relief for their symptoms. When these devices fail to work as intended, however, the results could be serious or even fatal.
At the Shelton Law Group, our experienced injury attorneys in Louisville understand that the use of any defective medical device can result in severe personal injury. As a recent FDA warning shows, when a defective device is used to regulate a condition such as diabetes, the consequences can be serious enough to issue a recall.
Medtronic Paradigm Insulin Pump Given Class I Risk Label
According to Mass Device, the FDA recent put their highest-risk label, a Class I, on a recall of Medtronic’s Paradigm insulin infusion pump. This was after Medtronic Canada said last month that it received two reports last month regarding the safety of its Paradigm and Polyfin infusion devices.
Medtronic said that the potential problem with the device involved either the over-delivery or under-delivery of insulin therapy, used to treat patients with type 1 and type 2 diabetes. The devices are used to infuse a programmed amount of insulin into patients and monitor blood sugar measurements from glucose meters.
When these devices fail, the potential exists for patients to receive inaccurate levels of insulin and could lead to serious health consequences such as hypoglycemia (a medical emergency involving low blood sugar) or hyperglycemia.
On July 12, the FDA said the Paradigm insulin pumps were recalled “because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of the tubing connector,” leading to a temporary blockage of the vents that allow the pump to operate properly.
How The FDA Regulates Medical Devices
The FDA’s official website states that the FDA is responsible for regulating companies that “manufacture, repackage, relabel, and/or import medical devices sold in the United States.” Manufacturers – not the FDA themselves – are held responsible for listing the medical devices they market with the FDA, safely manufacture their products, and properly label their medical devices.
Upon FDA approval, medical devices are classified into three categories. Class I devices present the lowest risk of causing personal injury. Class II devices face stricter regulations to hold manufacturers to high performance requirements, monitoring, and special labeling requirements. Class III devices are for devices for which insufficient information exists to determine a device’s safety.
When a product is recalled through the FDA, it could be either initiated by the manufacturer or due to either an FDA request or by legal FDA order. In the event of a class I recall, as is the case with the Paradigm insulin infusion pump, a device is found to have “reasonable probability” to cause serious health consequences or even death.
With Medtronic taking the initiative to warn patients, healthcare providers and pharmacies of a serious product defect, it’s likely that the company addressed the problem before a serious dangerous product accident occurred. When companies fail to do so, injured patients might have grounds for a defective medical devices lawsuit.
If you or a loved one was injured by a defective medical device, call Shelton Law Group today at 888-761-7204 for a free consultation with a Louisville attorney.