Medtronic MiniMed Recalls 620G and 640G Insulin Pumps for Bolus Screen Issue
Medtronic MiniMed is recalling 620G and 640G insulin pumps because the bolus screen may fail to timeout, displaying outdated dosing information.
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 (insulin pump) where a software defect could lead to inappropriate dosing, representing a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps. The recall involves specific models including the NGP 640G 1.8ml (mmol/L) Model No. MMT-1511, NGP 640G 1.8ml (mg/dL) Model No. 1512, NGP 640G PLGM 3ml (mmol/L) Model No. MMT-1711, and NGP 640G PLGM 3ml (mg/dL) Model No. MMT-1712. A total of 1,936 units are affected.
The recall is being conducted because there are scenarios where the set Bolus screen will not timeout. This malfunction could cause confusion by showing a bolus amount that is no longer appropriate. The affected devices were distributed in Australia, the Czech Republic, Denmark, Finland, France, Ireland, the Netherlands, Norway, Sweden, and the United Kingdom.
Consumers should contact Medtronic MiniMed for instructions on how to proceed with the recall.
The recalled product
- Product
- MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712.
- Manufacturer
- Medtronic MiniMed Inc.
- Category
- Medical Device — Insulin Pump
- Affected units
- 1,936
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 (1)
- n/a
Distribution
Distribution scope not specified by the agency.
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