Medtronic plc. Ordinary Shares (NYSE:MDT) has announced that some of its MiniMed infusion sets were being recalled over concerns that there was a risk of overdelivery of insulin thereby putting the lives of patients at the risk of hypoglycemia. Most of the insulin sets that are being recalled were manufactured prior to April.
According to the Medtronic’s Diabetes Group chief medical officer, Francine Kaufman, the complication happens when a membrane which is vital in releasing pressure contained inside the pump becomes wet resulting in the vents being blocked. The greatest risk of insulin overdose occurs when the infusion set is changed by the patient. Typically the insulin set is changed after every three days.
The Food and Drug Administration, as well as other regulators across the globe have been contacted by Medtronic. The medical devices manufacturer will cooperate with regulators and governments as the global voluntary recall gets underway.
“Our priority is to work with our patients to mitigate risk to patient safety. While we have shipped a significant number of the new and enhanced sets since April, we are committed to replacing recalled infusion sets for all patients,” said Kaufman.
So far no death has been reported that is related to insulin overdelivery. According to Kaufman majority of the patients were able to tell that their blood sugar levels had fallen too low and consequently were able to self-correct. Some patients resorted to calling an ambulance and were rushed to hospital.
Per Annette Bruls, a president at Medtronic, patients who have an infusion set which is inserted and which is in working condition do not need to do anything. Medtronic has also announced that the problem has been fixed and patients can use devices which were made after March this year.
The Dublin-based medical devices manufacturer has also revealed that the recall costs would mostly be incurred in this fiscal year’s second quarter. How much will be spent on the recall will be depend on the number of unused sets that will be returned.
On Monday the stock of Medtronic Plc fell by 0.57% to close the day at $81.56 a share.