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