Recall Z-2377-2018 ยท FPA Set, Administration, Intravascular
Medtronic Inc.
Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754
| Date | Jul 5, 2018 (initiated Apr 24, 2018) |
| Status | Terminated |
| Reason | The MiniMed Paradigm Veo insulin pump has an error that impacts the Arabic language translation.This translation error occurs in the Predictive Alerts setting screen, which allows user to program alerts that will sound if users are predicted to reach their pre-set low or high sensor glucose values. |
| Root cause | Under Investigation by firm |
| Action | Medtronic Inc. conducted this field corrective action via Urgent Field Safety Notification to customers: patients and health care providers. |
| Quantity | 239,859 |
| Distribution | International only. No U.S. distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.