Recall Z-0683-2019— Medtronic Inc.

Name: FDA recall Z-0683-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-03

Class II · Ongoing

Class II FDA medical device recall by Medtronic Inc., initiated 2018-10-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International). 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: Medtronic Inc.
Classification: Class II
Status: Ongoing
Initiated: 2018-10-03
Firm location: Northridge, CA, United States

Product description

Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.