Company: Medtronic Inc.
Date of Enforcement Report: 12/22/2018
Class II
PRODUCT
Medtronic MiniMed 630G 6025805-003_C, Rx Only
Medtronic MiniMed 670G 6025805-005_B, Rx Only
Medtronic MiniMed 640G (International)
Recall Number: Z-0683-2019
REASON
Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts.
RECALLING FIRM/MANUFACTURER
Medtronic Inc., Northridge, CA on 10/3/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
142889
DISTRIBUTION
U.S. Nationwide