Medtronic Recalls Diabetes Infusion Sets for Overdose Risk

  • 1 in 2 million sets susceptible to excess insulin delivery
  • Company to replace sets at no cost; no financial details given

The Medtronic headquarters building stands in Minneapolis, Minnesota.

Photographer: Ariana Lindquist/Bloomberg
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Medtronic Plc is recalling a disposable device used with the company’s insulin pumps, after discovering that the part can trigger an excessive dose of the drug and put patients at risk of hypoglycemia.

About one in every two million infusion sets manufactured before April may be associated with the complication, which occurs when a membrane that’s used to release pressure from inside the pump gets wet and blocks the vents, said Francine Kaufman, chief medical officer of Medtronic’s diabetes group. The risk of an excessive insulin dose is greatest right after the patient changes the infusion set, which is done every three days, she said.