Medtronic recalled its infusion sets — or disposable devices used to connect insulin pumps to the body — over malfunction issues, reports Bloomberg.
Medtronic issued the recall after learning of a product error that can cause infusion sets to release an excessive dose of insulin, putting diabetes patients at risk of hypoglycemia.
The issue applies to only one in every two million infusion sets manufactured before April, according to Francine Kaufman, MD, CMO of Medtronic's diabetes group. Patients are at greatest risk for insulin over-delivery when swapping out the infusion set, which they must do every three days, Dr. Kaufman told Bloomberg.
Most patients who experienced the issue recognized their blood sugar had dropped and treated the condition accordingly. Others called an ambulance, went to the hospital or visited their physician, according to the report. No patient deaths have been associated with the faulty devices.
Medtronic fixed the product issue, and all infusion sets produced since April are safe to use. Medtronic also created a website where patients can learn if their infusion sets are part of the recall. The devicemaker is exchanging the older infusion sets for free.
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