Recall – Medtronic MiniMed Paradigm Vea Insulin Pump

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

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)

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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