Recall Z-1890-2017— Medtronic Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc., initiated 2017-01-31, terminated 2017-05-04. FDA's recall record names no specific 510(k) clearance for this event. Product: MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712.. Reason: Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. When the software anomaly occurs it leads to battery depletion and pump shutdown..
- Recalling firm
- Medtronic Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-31
- Terminated
- 2017-05-04
- Firm location
- Northridge, CA, United States
Product description
MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712.
Reason for recall
Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. When the software anomaly occurs it leads to battery depletion and pump shutdown.
Data sourced from openFDA. This site is unofficial and independent of the FDA.