Medtronic MiniMed Paradigm Model 511 Insulin Pump Recall for Cybersecurity Vulnerabilities
Medtronic MiniMed is recalling 30,479 Paradigm Model 511 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 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 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 30,479 units of the MiniMed Paradigm Model 511 Insulin Pump. The recall covers all software versions and includes products distributed nationwide in the United States, including Puerto Rico.
The action is being initiated due to potential cybersecurity vulnerabilities related to the insulin 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 with this product should contact Medtronic MiniMed for instructions on how to proceed with the recall.
The recalled product
- Product
- MiniMed Paradigm Model 511 Insulin Pump
- Manufacturer
- Medtronic MiniMed
- Category
- Medical Device — Insulin Pump
- Affected units
- 30,479
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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