Recall Z-0517-2021— Medtronic Inc.

Name: FDA recall Z-0517-2021
Creator: U.S. Food and Drug Administration
Published: 2020-04-30

Class II · Ongoing

Class II FDA medical device recall by Medtronic Inc., initiated 2020-04-30. FDA's recall record names no specific 510(k) clearance for this event. Product: MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage: intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, fourteen years of age and older, requiring insulin.. Reason: Missing solder battery connection, which could interrupt power of insulin pump..

Recalling firm: Medtronic Inc.
Classification: Class II
Status: Ongoing
Initiated: 2020-04-30
Firm location: Northridge, CA, United States

Product description

MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage: intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, fourteen years of age and older, requiring insulin.

Reason for recall

Missing solder battery connection, which could interrupt power of insulin pump.

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