Recall Z-1582-2020— Medtronic MiniMed
Class II · Ongoing
Class II FDA medical device recall by Medtronic MiniMed, initiated 2019-06-27. It names one FDA 510(k) clearance: K041318. Product: MiniMed Paradigm Model 511 Insulin Pump. 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
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
MiniMed Paradigm Model 511 Insulin Pump
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.