Medtronic MiniMed Mio Infusion Sets Recalled for Potential Insulin Over-Delivery
Medtronic is recalling MiniMed Mio infusion sets because they may over-deliver insulin. The recall covers 1,513,530 units distributed worldwide.
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 medical device with a risk of harm (insulin over-delivery) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Medtronic Inc. is recalling Medtronic MiniMed(TM) Mio(TM) infusion sets (models MMT-921 through 975T) due to a potential for over-delivery of insulin. The recall affects 1,513,530 units that were distributed worldwide.
The source text identifies the hazard as the potential for the infusion sets to deliver more insulin than intended. No specific lot numbers, dates, or injury reports are provided in the source text.
Consumers with these infusion sets should contact Medtronic or their healthcare provider for instructions on how to proceed. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
- Manufacturer
- Medtronic Inc.
- Hazard
- Affected units
- 1,513,530
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Medtronic Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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