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