Medical device manufacturer Medtronic has issued a Class I recall of approximately 120,000 MiniMed 780G insulin pumps due to a software defect that could cause the device to deliver incorrect insulin doses. The FDA has classified this as the most serious type of recall due to the potential for life-threatening consequences.
The issue involves a rare software condition where the pump's auto-mode algorithm may calculate an incorrect correction bolus during periods of rapidly changing glucose levels. This could result in either too much or too little insulin delivery.
Medtronic has reported 15 adverse events potentially related to the defect, including 4 hospitalizations for severe hypoglycemia. No deaths have been reported. The company is issuing an urgent software update that can be downloaded remotely to affected devices.
Patients using affected pumps are advised to continue using their devices but to monitor glucose levels more frequently until the update is installed. Healthcare providers have been notified to watch for unusual glucose patterns in their patients.
The recall underscores the challenges of AI-driven medical devices, as the 780G's auto-mode feature uses algorithmic decision-making to adjust insulin delivery in real-time based on continuous glucose monitor data.
