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."
Coats blasts the medtech tax amid IRS bungle
Senator Dan Coats (R-Ind.) renewed calls for repeal of the 2.3% medical device tax after an IRS audit revealed that the agency is having trouble keeping tabs on the levy.
Study: Knee surgery’s not always the answer
Patients with mild osteoarthritis get little relief from surgery to treat degenerative meniscal tears, according to a meta-analysis published in CMAJ.
Veterans Affairs back medical-grade activity trackers
The Dept. of Veterans Affairs agreed to provide reimbursement for physicians who prescribe clinical-grade activity trackers for monitoring patients.