Company: Medtronic Inc.
Date of Enforcement Report: 7/11/2018
Class II:

PRODUCT
Medtronic MiniMed Paradigm Vea Insulin Pump Product Catalog Number: MMT-554, MMT-754 Recall Number: Z-2377-2018

REASON
Medtronic notified customers/users of MiniMed” Paradigm” Veo” insulin pump that the 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/MANUFACTURER
Medtronic Inc., Northridge, CA on 4/24/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
239,859

DISTRIBUTION
Internationally (no US)