Medtronic MiniMed Quick-set Infusion Sets Recalled for Insulin Over-delivery Risk
Medtronic is recalling MiniMed Quick-set infusion sets because they may deliver too much insulin. The recall covers 3,971,030 units distributed worldwide.
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, and the hazard involves a risk of harm (insulin over-delivery) without reported injuries or illnesses in the source text, which aligns with the 'High' severity criteria.
Plain-English summary
Medtronic Inc. is recalling Medtronic MiniMed(TM) Quick-set(TM) infusion sets (models MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T). The recall involves 3,971,030 units that were distributed worldwide.
The recall is being conducted because the infusion sets have the potential for over-delivery of insulin. This hazard could result in patients receiving more insulin than prescribed.
Consumers and healthcare providers should check their infusion sets against the specific lot numbers listed in the official recall notice. If a set is affected, users should stop using it and contact Medtronic or their healthcare provider for instructions on replacement or further action.
The recalled product
- Product
- Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
- Manufacturer
- Medtronic Inc.
- Hazard
- Affected units
- 3,971,030
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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