Recall Z-0516-2021— Medtronic Inc.

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 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and detecting possible low and high glucose episodes. When using a sensor and transmitter, the pump displays continuous sensor glucose values and stores this data so that it can be analyzed to track patterns and improve diabetes management. This data can be uploaded to a computer for analysis of historical glucose values.. 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 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and detecting possible low and high glucose episodes. When using a sensor and transmitter, the pump displays continuous sensor glucose values and stores this data so that it can be analyzed to track patterns and improve diabetes management. This data can be uploaded to a computer for analysis of historical glucose values.

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.