Medtronic MiniMed Silhouette Infusion Sets Recalled for Insulin Over-Delivery Risk
Medtronic is recalling MiniMed Silhouette infusion sets because they may over-deliver insulin. The recall covers 1,898,570 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. The hazard involves a risk of harm (insulin over-delivery) without reported illnesses or injuries in the source text, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Inc. is recalling Medtronic MiniMed(TM) Silhouette(TM) infusion sets (models MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T) due to a potential for over-delivery of insulin. The recall involves 1,898,570 units that were distributed worldwide.
The recall is classified as Class II by the U.S. Food and Drug Administration. The source text does not specify reported injuries, illnesses, or specific corrective actions for consumers beyond the recall notice itself.
The recalled product
- Product
- Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
- Manufacturer
- Medtronic Inc.
- Hazard
- Affected units
- 1,898,570
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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