Medtronic MiniMed 640G Insulin Pumps Recalled for Chemical Damage Risk
Medtronic is recalling 16 MiniMed 640G insulin pumps distributed in Europe because chemical cleaning may have damaged the devices, risking incorrect insulin delivery.
What this means for you
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 involves a high-risk medical device where a defect could cause serious harm (diabetic ketoacidosis), but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medtronic MiniMed, Inc. is recalling 16 units of the MiniMed 640G Insulin Pump, models MMT-1711 and MMT-1712. These specific loaner devices were distributed internationally to Germany, Denmark, Austria, the Netherlands, the United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, and Northern Ireland.
The recall is due to the potential use of chemically incompatible cleaning products on the loaner pumps. Such chemicals could damage the pump case or keypad, allowing moisture to enter the device. This damage could result in the over-delivery or under-delivery of insulin.
Incorrect insulin delivery can lead to serious health consequences, including hypoglycemia, hyperglycemia, or diabetic ketoacidosis. Users of the affected serial numbers should contact Medtronic MiniMed for instructions on how to proceed.
The recalled product
- Product
- MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Insulin Pump
- Affected units
- 16
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- Model/UDI-DI/Serial Numbers: MMT-1711/00763000404550/NG2660048H
- NG2663343H
- NG3015306H
- MMT-1712/00763000404567/NG2628486H
- NG2758213H
- NG2999651H
- NG3349198H
- NG3351719H
- NG2678842H
- NG2831821H
- NG2831546H
- NG2932027H
- NG3049657H
- NG3033094H
- NG2831538H
- NG3738739H
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Medtronic MiniMed, Inc.
See all →- SevereMedtronic MiniMed 670G Insulin Pumps Recalled Due to Chemical Damage Risk
FDA (Devices) · 2026-08-26
- HighMedtronic MiniMed 780G Insulin Pumps Recalled for Chemical Damage Risk
FDA (Devices) · 2026-08-26
- HighMiniMed Go App Recalled Due to Missed Insulin Alerts
FDA (Devices) · 2026-07-29
- HighMiniMed 780G Insulin Pump Software Anomaly Recall
FDA (Devices) · 2026-07-15
- HighMiniMed 700G insulin pump delivery varies with pump height changes
FDA (Devices) · 2026-04-08
Same hazard · chemical damage
See all →- HighBaxter MiniCap PD Transfer Sets may leak or crack with certain cleaners
FDA (Devices) · 2022-02-16
- HighBaxter CAPD Transfer Sets may crack or leak when exposed to cleaning chemicals
FDA (Devices) · 2022-02-16
- HighBaxter Peritoneal Dialysis Transfer Sets Recalled for Chemical Damage Risk
FDA (Devices) · 2022-02-16
- HighBaxter CAPD Transfer Sets May Leak if Cleaned with Certain Chemicals
FDA (Devices) · 2022-02-16
- HighBaxter MiniCap PD Transfer Set Recall—Damage from Cleaning Products
FDA (Devices) · 2022-02-16