Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerabilities
Medtronic MiniMed is recalling 23,221 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
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 agency classification is FDA Class II. The hazard involves unauthorized control of a critical medical device (insulin pump), which poses a significant risk of serious injury or death if insulin delivery is manipulated, fitting the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Medtronic MiniMed is recalling 23,221 units of the MiniMed Paradigm Insulin pump, model number MMT-523. The recall affects all software versions 2.4A or lower. The product was distributed nationwide in the United States, including Puerto Rico.
The recall is being initiated due to potential cybersecurity vulnerabilities related to the pumps' wireless radio frequency (RF) communication capabilities. An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.
Consumers who have this specific model and software version should contact Medtronic MiniMed for instructions on how to proceed. The source text does not provide specific contact details or a deadline for action.
The recalled product
- Product
- Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
- Manufacturer
- Medtronic MiniMed
- Category
- Medical Device — Insulin Pump
- Affected units
- 23,221
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 (1)
- All software versions 2.4A or lower
Distribution
Part of a larger recall action
This product is one of 16 recalled by Medtronic MiniMed 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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