Beginning in April 2013, the Medtronic Paradigm® Insulin Pump has been the subject of a number of medical device safety alerts and recalls issued by its manufacturer and the U.S. Food and Drug Administration (FDA). The most serious of these notices include recalls of Medtronic MiniMed Paradigm Insulin Infusion Sets and Infusion Set Reservoirs.
During the week of April 17, 2013, the FDA issued a Class II recall of certain models of the Medtronic MiniMed Paradigm Insulin Infusion Pump, intended for use to deliver insulin to people with diabetes. Medtronic recalled the pumps because the pump’s drive support cap may become detached from the pump case and protrude from the lower right side of the pump. When the pump is exposed to water, it may result in damage to the pump’s internal electronics, which can prevent the pump’s buttons from working properly or can cause the pump to alarm. The recall includes about 428,000 units distributed worldwide.
On June 7, 2013, the FDA issued a Class I Recall on certain models of the Medtronic MiniMed Paradigm Infusion Sets. A Class I recall is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. If insulin or other fluids come in contact with the inside of the tubing connector, it can temporarily block the vents that allow the pump to properly prime.
If the pump’s vents are blocked, this can result in too much or too little insulin being delivered, which may cause hypoglycemia or hyperglycemia. In extreme cases, these conditions may cause loss of consciousness or death. The Paradigm infusion sets are intended for use with the Paradigm insulin infusion pump. Infusion sets are used by patients with diabetes who require administered insulin to maintain acceptable blood glucose levels.
On July 3, 2013, Medtronic sent an urgent medical device recall notice to its customers alerting them of problems with certain lots of MMT-326A and MMT-332A Reservoirs used with Paradigm Insulin Pumps. According to the notice, the recall was issued because of the potential for the reservoirs to leak. A leak in the reservoir may result in delivery of less insulin than intended. Also, a leak may lead to an insulin blockage in the infusion set, and a failure of the device to sound an alarm to notify patients. Medtronic says the defect is caused by abnormal wear on a tool used to manufacture reservoir stoppers. They are recalling all lots of reservoirs that contain stoppers manufactured with this tool.
Lawyers in our firm are currently investigating claims of serious injury or death as a result of a defective Medtronic Paradigm® Insulin Pumps, Medtronic MiniMed Paradigm Insulin Infusion Sets and Medtronic Infusion Set Reservoirs. As a side note, some of those potential claims involve folks who were injured as a result of automobile accidents possibly caused by these devices. If you would like more information about this, please contact, Ted Meadows, a lawyer in our firm’s Mass Tort’s section, at 1-800-898-2034, or at Ted.Meadows@beasleyallen.com.