MASSDEVICE ON CALL — FDA medical device regulators reported this month that industry giant Medtronic (NYSE:MDT) issued a recall affecting nearly 560,000 units of its MiniMed Paradigm Infusion pumps.
Medtronic is not asking for the devices back, but is advising users to take extra care when programming their insulin dosage. The company has received reports that patients have accidentally programmed their insulin pumps to deliver the maximum bolus amount.
The FDA report follows Medtronic’s March 2014 letter to customers, in which the company cautioned users about accidental button pressing and advised that users always double-check their dosage on the pump’s display.
There are more than 559,000 affected Paradigm infusion pumps in global distribution, about 444,000 of them in the U.S., according to the FDA memo.
The federal watchdog agency gave the recall its medium-risk Class II label, designating "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."
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