Medtronic MiniMed Paradigm Insulin Pumps Recalled for Programming Error
Medtronic is recalling MiniMed Paradigm insulin pumps because users may have accidentally programmed them to deliver the maximum bolus amount.
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 involves a medical device where a programming error could lead to incorrect insulin dosing, representing a risk of harm where injury has not yet been reported in the source text.
Plain-English summary
Medtronic MiniMed Inc. is recalling specific models of Medtronic MiniMed Paradigm Insulin Infusion Pumps and MiniMed 530G systems. The recall involves 559,374 units total, with 444,374 units distributed in the United States. The affected devices are intended for use to deliver basal and bolus insulin to persons with diabetes.
The recall was initiated because Medtronic received reports that users have accidentally programmed the pump to deliver the maximum bolus amount. This programming error could result in the delivery of an incorrect dose of insulin.
Consumers who use these devices should contact Medtronic MiniMed Inc. for instructions on how to proceed. The recall covers specific model numbers and code identifiers listed in the official FDA notice.
The recalled product
- Product
- Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. MiniMed 530G: MMT-551, and MMT-751 Paradigm…
- Manufacturer
- Medtronic MiniMed Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Paradigm: MMT-523NAB
- MMT-723KNB
- MMT-523NAH
- MMT-723KNH
- MMT -523NAL
- MMT-723KNL
- MMT-523NAP
- MMT-723KNP
- MMT-523NAS
- MMT-723KNS
- MMT-723NAB
- MMT-723NAH
- MMT-723NAL
- MMT-723NAP
- MMT-723NAS
- MMT-523KNB
- MMT-523KNH
- MMT-523KNL
- MMT-523KNP
- MMT-523KNS. MiniMed 530G: MMT-551NAM
Distribution
Distributed nationwide across the United States.
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