The U.S. Food and Drug Administration recently announced that it had classified Medtronic’s recall of its MiniMed Paradigm Infusion pumps as a Class II recall. This will affect nearly 560,000 units.
In March the company sent a letter to customers with the MiniMed Paradigm, in which the company cautioned users about accidental button pressing and advised that they always double-check their dosage on the pump’s display. Medtronic is not asking for the devices back at this time but is advising users to take extra care when programing their insulin dosages into the pumps. This warning came after reports that patients have accidentally programmed their insulin pumps to deliver the maximum bolus amount.
Last year the industry giant also issued another recall concerning the Paradigm insulin pumps that was classified as a Class I recall – the agency’s most serious label. That recall involved a mechanical issue with a part malfunction that could lead to the delivery of too much or too little insulin. That action affected Paradigm infusion sets, which are used with Medtronic’s Paradigm insulin pumps.
Also, in Australia last year, Medtronic also faced an Australian safety advisory concerning nine models of Paradigm insulin pumps, due to issues including loose parts and sensor graph malfunctioning.
Patients who have Medtronic Paradigm pumps need to know about these recalls because they are facing potentially dangerous health situations. Information regarding the Medtronic Paradigm recalls can be found on the FDA’s MedWatch site, http://www.fda.gov/Safety/MedWatch/