Medtronic MiniMed Infusion Sets Recalled Due to Tubing Detachment Risk
Medtronic MiniMed is recalling Silhouette and Sure-T infusion sets because tubing may detach, interrupting insulin delivery without an alarm.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of serious injury (diabetic ketoacidosis) due to interrupted insulin delivery, meeting the criteria for a Severe rating.
Plain-English summary
Medtronic MiniMed Inc. is recalling specific models of Silhouette and Sure-T insulin infusion sets, including Paradigm Silhouette and MiniMed Duo sensor/infusion sets. The recall involves approximately 12.4 million units in the United States and 8.3 million units internationally.
The recall is issued because the tubing may detach at the connect/disconnect location. If this occurs, insulin delivery is interrupted, and the pump does not alarm to notify the patient. This failure can lead to hyperglycemia and diabetic ketoacidosis (DKA).
The affected products were distributed worldwide, including nationwide in the United States and in numerous other countries. Patients using these infusion sets should contact Medtronic MiniMed for instructions on how to proceed.
The recalled product
- Product
- Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377, MMT-377600, MMT378, MMT-378600, MMT-38 1, MMT-381 600, MMT-382, MMT-382600, MMT-383, MMT-383600, MMT384, & MMT384600. Sure-T…
- Manufacturer
- Medtronic MiniMed Inc.
Distribution
Distributed nationwide across the United States.
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