Recall Z-1592-2020— Medtronic MiniMed
Class II · Ongoing
Class II FDA medical device recall by Medtronic MiniMed, initiated 2019-06-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K. Reason: The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery..
- Recalling firm
- Medtronic MiniMed
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-06-27
- Firm location
- Northridge, CA, United States
Product description
Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
Reason for recall
The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.
Data sourced from openFDA. This site is unofficial and independent of the FDA.