PlainRecalls
FDA Devices Moderate Class II Ongoing

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 gl

Reported: December 9, 2020 Initiated: April 30, 2020 #Z-0516-2021

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.

Details

Recalling Firm
Medtronic Inc.
Units Affected
391
Distribution
Worldwide distribution - U.S. Nationwide Distribution in the state of MD and the countries of Canada, Netherlands, Norway. ***Model 630G distributed in Canada and Model 670G distributed in US ***MODEL640G Distributed OUS ONLY*** OUS: Australia, Canada, Netherlands and Norway.
Location
Northridge, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Medtronic Inc.. Units affected: 391.
Why was this product recalled?
Missing solder battery connection, which could interrupt power of insulin pump.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 9, 2020. Severity: Moderate. Recall number: Z-0516-2021.