Medtronic MiniMed Paradigm Reservoirs Recalled for Potential Leaking Risk
Medtronic is recalling specific lots of Paradigm insulin reservoirs because they may leak, potentially delivering less insulin than intended.
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 under-delivery) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Medtronic MiniMed is recalling certain lots of Paradigm Reservoirs, models MMT-326A (1.8mL) and MMT-332A (3.0mL). These syringe-type insulin reservoirs are intended for use with Medtronic Paradigm series insulin infusion pumps. The recall involves 669,672 units distributed worldwide, including the United States and various international locations.
The recall is being conducted because the reservoirs may have an increased risk for leaking. A leak in the reservoir may result in the delivery of less insulin than intended. Additionally, if a leaky reservoir is present and an insulin blockage occurs in the infusion set, the pump may not function as expected.
Consumers should check their reservoir lot numbers against the list provided in the official recall notice. If the lot number matches, they should stop using the product and contact Medtronic MiniMed for instructions on replacement or return.
The recalled product
- Product
- Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for…
- Manufacturer
- Medtronic MiniMed
- Affected units
- 669,672
Distribution
Distributed nationwide across the United States.
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