Medtronic Recalls MiniMed 620G and 640G Insulin Pumps Due to Software Anomaly
Medtronic is recalling MiniMed 620G and 640G insulin pumps with software version 2.6 or below because a software anomaly can prevent the internal battery from charging, leading to pump shutdown.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a critical medical device (insulin pump) shutting down due to battery depletion, which poses a significant risk of harm to users, but no specific injuries or deaths are reported in the source text.
Plain-English summary
Medtronic Inc. is recalling 42,215 units of MiniMed 620G and MiniMed 640G insulin pumps. The affected devices are those with software version 2.6 and below, identified by catalog numbers MMT-1510, MMT-1710, MMT-1711, and MMT-1712.
The recall is due to a software anomaly that can prevent the internal battery of the pump from charging. When this anomaly occurs, it leads to battery depletion and subsequent pump shutdown. The affected units were distributed in Europe, Australia, Japan, and Singapore.
Consumers should check their pump's software version and serial number against the list of affected units. If the device is affected, users should contact Medtronic for instructions on how to proceed, as the pump may stop functioning due to battery depletion.
The recalled product
- Product
- MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712.
- Manufacturer
- Medtronic Inc.
- Category
- Medical Device — Insulin Pump
- Affected units
- 42,215
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Medtronic Inc.
See all →- HighMedtronic Sphere-9 Catheter may cause ventricular fibrillation with Biotronik ICDs
FDA (Devices) · 2026-05-06
- HighVenous stents recalled over a nitinol anomaly that reduces deployed diameter
FDA (Devices) · 2026-01-21
- ModerateKidney tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- HighSmartSync Patient Connector limited the window to abort high voltage therapy
FDA (Devices) · 2025-07-30
- HighCareLink SmartSync limited the window to abort a high voltage therapy
FDA (Devices) · 2025-07-30
Same hazard · software anomaly
See all →- HighMiniMed 780G Insulin Pump Software Anomaly Recall
FDA (Devices) · 2026-07-15
- HighPlum Solo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- HighPlum Duo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- HighPlum Duo infusion pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- SevereIvenix pump software may report false battery health and shut down
FDA (Devices) · 2026-06-10
Similar recalls
- HighMiniMed 640G Insulin Pumps Recalled for Battery Cap Deterioration
FDA (Devices) · 2022-07-20
- HighMedtronic MiniMed 640G Insulin Pumps Recalled for Motor Malfunction
FDA (Devices) · 2015-12-23
- HighMedtronic Recalls MiniMed 620G Insulin Pumps Due to Keypad Malfunction
FDA (Devices) · 2017-06-28
- HighMedtronic MiniMed 620G Insulin Pump Recall for Motor Malfunction
FDA (Devices) · 2015-12-23
- HighMedtronic Recalls MiniMed 640G Insulin Pumps Due to Keypad Malfunction
FDA (Devices) · 2017-06-28
- HighMedtronic Recalls MiniMed 630G Insulin Pumps Due to Keypad Malfunction
FDA (Devices) · 2017-06-28