Medtronic MiniMed Paradigm Insulin Pumps Recalled for Cybersecurity Vulnerability
Medtronic MiniMed is recalling 73,028 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
What this means for you
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 harm, but the source text describes the risk as potential and does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medtronic MiniMed is recalling 73,028 MiniMed Paradigm insulin pumps, model numbers MMT 515 and MMT-715, across all software versions. The recall is being initiated due to potential cybersecurity vulnerabilities related to the pumps' wireless radio frequency (RF) communication capabilities.
The hazard involves the potential for an unauthorized person to connect wirelessly to a nearby insulin pump. If this occurs, the unauthorized user could potentially change settings and control insulin delivery. The affected units were distributed nationwide in the United States, including Puerto Rico.
Consumers should contact Medtronic MiniMed for instructions on how to proceed with the recall and to determine if their specific device is affected.
The recalled product
- Product
- Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715
- Manufacturer
- Medtronic MiniMed
- Category
- Medical Device — Insulin Pump
- Affected units
- 73,028
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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