Medtronic MiniMed Insulin Pumps Recalled for Cybersecurity Vulnerabilities
Medtronic MiniMed is recalling 64,174 MiniMed Insulin Pumps (model MMT-508) due to potential 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 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 high-risk medical device where unauthorized control could lead to serious harm, but the source text describes the risk as 'potential' and does not report any actual injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medtronic MiniMed is recalling 64,174 units of the MiniMed Insulin Pump, model # MMT-508, across all software versions. The recall is being initiated due to potential cybersecurity vulnerabilities related to the device's wireless radio frequency (RF) communication capabilities.
The hazard involves the possibility that an unauthorized person could connect wirelessly to a nearby insulin pump to change settings and control insulin delivery. This risk applies to units distributed nationwide in the United States, including Puerto Rico.
Consumers with this specific model of insulin pump should contact Medtronic MiniMed for further instructions on how to address the cybersecurity vulnerability.
The recalled product
- Product
- MiniMed Insulin Pump, model # MMT-508
- Manufacturer
- Medtronic MiniMed
- Category
- Medical Device — Insulin Pump
- Affected units
- 64,174
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
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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