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.
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 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.
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