Medtronic MiniMed is voluntarily recalling certain manufacturing lots of model MMT-326A (Paradigm Reservoir 1.76ml) and MMT-332A (Paradigm Reservoir 3 ml) insulin reservoirs used with our Paradigm insulin pumps. The company is recalling these reservoirs due to the potential that reservoirs from these lots are at increased risk for leaking. A leak in the reservoir may result in delivery of less insulin than intended and, if there is an occlusion in the infusion set, the pump may not alarm.The company’s investigation has indicated that this increased potential for reservoir leakage is related to abnormal wear of a manufacturing tool involved in the production of a component used in the affected lots of reservoirs. Medtronic Minimed has implemented additional testing and inspection steps to ensure that currently produced reservoirs will not be subject to this problem.
Pump users need to log on to www.medtronic-diabetes.info to check if their lot is affected.