A number of medical device safety alerts and recalls have been issued by Medtronic and the U.S. Food and Drug Administration (FDA) regarding the Medtronic MiniMed Paradigm® Insulin Infusion Pump and related products. The most serious of these notices include recalls of Medtronic MiniMed Paradigm Insulin Infusion Sets and Infusion Set Reservoirs.
The week of April 17, 2013, the FDA issued a Class II recall of the Medtronic MiniMed Paradigm Insulin Infusion Pump, intended for use to deliver insulin to people with diabetes. 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.
On June 7, 2013, the FDA issued a Class I Recall on Medtronic MiniMed Paradigm Infusion Sets. 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 potentially 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.
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 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.
Beasley Allen is 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.
For more information, lot numbers of recalled products, and copies of the FDA Recall and Medtronic Urgent Safety notices, visit our Medtronic Insulin Pump page.