Recall Z-2377-2018— Medtronic Inc.

Class II · Terminated

Class II FDA medical device recall by Medtronic Inc., initiated 2018-04-24, terminated 2022-05-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754. 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..

Recalling firm
Medtronic Inc.
Classification
Class II
Status
Terminated
Initiated
2018-04-24
Terminated
2022-05-02
Firm location
Northridge, CA, United States

Product description

Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.