The US Food and Drug Administration (FDA) has issued a Class I recall of Medtronic’s MiniMed Paradigm Insulin Infusion Sets.
The Paradigm infusion sets are meant for use with Paradigm insulin infusion pumps. These infusion sets are used by patients with diabetes mellitus who need to be administered with insulin in order to maintain acceptable blood glucose levels.
FDA issued a class I recall recall on the insulin device due to potential safety issue with the insulin or other fluids which come in contact with the inside of the tubing connector.
If this occurs it can temporarily block the vents that allow the pump to properly prime which results in delivering either too much or too little of insulin, resulting in hypoglycemia or hyperglycemia, which can be severe and may even lead to serious illness.
Medtronic has already issued an urgent medical device safety notification to healthcare professionals to let them know about the potential disasters of over or under delivery of insulin if the insulin or other fluids contact the inside of Medtronic Paradigm Tubing Connectors.
This recall is applicable to all the firm's infusion sets, which intended to be used with its Paradigm family infusion pumps with MMT models including MMT-317, 318, 324, 325, 312S, 312L, 386, 387, 394, 396, 397, 398, 399, 377, 378, 381, 382, 383, 384, 368, 862, 864, 866, 874, 876, 884, 886, 921, 923, 925, 941, 943, 945, 961, 963, 965, & 975 Paradigm Infusion sets.
The affected products were manufactured from October 2001 through June 2013 and distributed from December 2001 through June 2013.