FDA recall Z-2377-2018

Medtronic Inc. · Class II · device

Product

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.

Distribution

International only. No U.S. distribution

Key facts

Status: Terminated
Initiation date: 2018-04-24
Report date: 2018-07-11
Termination date: 2022-05-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Northridge, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2377-2018