Recall – Insulin pump error may lead to over delivery

Company: Medtronic
Date of Enforcement Report: 6/9/2021
Class II

PRODUCT

Multiple MiniMed 780G Insulin Pump Models

Recall Number: Z-1771-2021

REASON

Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if the user is not aware of the amount of active insulin and delivers an additional bolus, there is a risk of insulin over delivery.

RECALLING FIRM/MANUFACTURER

Medtronic on 3/15/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

15,682 devices

DISTRIBUTION

U.S. Nationwide and International

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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