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.
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 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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