Recall Z-0194-2023— Medtronic MiniMed
Class II · Ongoing
Class II FDA medical device recall by Medtronic MiniMed, initiated 2022-09-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752. Reason: Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow unauthorized access to the pump system. This unauthorized access could be used to deliver too much or too little insulin through delivery of an unintended insulin bolus or because insulin delivery is slowed or stopped, which could lead to hypoglycemia or hyperglycemia. The Remote Bolus feature on insulin pumps should be turned off to prevent the unauthorized access..
- Recalling firm
- Medtronic MiniMed
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-09-20
- Firm location
- Northridge, CA, United States
Product description
Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752
Reason for recall
Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow unauthorized access to the pump system. This unauthorized access could be used to deliver too much or too little insulin through delivery of an unintended insulin bolus or because insulin delivery is slowed or stopped, which could lead to hypoglycemia or hyperglycemia. The Remote Bolus feature on insulin pumps should be turned off to prevent the unauthorized access.
Data sourced from openFDA. This site is unofficial and independent of the FDA.