Medtronic has initiated a voluntary recall of 38,000 MiniMed 780G insulin pumps after identifying a software bug that could cause the device to deliver incorrect insulin doses under specific conditions, posing serious hypoglycemia risks.
Problem Description
The defect occurs when the pump's auto-mode algorithm receives conflicting signals from the continuous glucose monitor during rapid blood sugar changes, potentially delivering up to 1.5 times the intended correction dose.
- 15 adverse events reported, including 4 hospitalizations for severe hypoglycemia
- Affected units manufactured between January and October 2025
- Software update available immediately via the MiniMed mobile app
Patient Guidance
The FDA recommends patients continue using their pumps but switch to manual mode until the software update is applied. Healthcare providers have been alerted to monitor patients using affected devices more closely during the transition period.