FDA Recall Terminated

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

Recall: Z-2377-2018 · Initiated April 24, 2018

Recall

Recall Number
Z-2377-2018
Event Number
80320
Firm
Medtronic Inc.
FEI Number
3003166194
Product Code
FPA
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
April 24, 2018
Posted
July 5, 2018
Terminated
May 2, 2022
Address
18000 Devonshire St, Northridge, CA, 91325-1219

Description

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.

Action

Medtronic Inc. conducted this field corrective action via Urgent Field Safety Notification to customers: patients and health care providers.

Distribution

International only. No U.S. distribution

Quantity

239,859