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Recall Observatory FDA recall evidence

Device product

MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only - Product Usage: indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Z-0518-2021

April 30, 2020

Class II

Product summary

Firm
Medtronic Inc.
Event
Event 85711
Status
Ongoing
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-0518-2021

Official wording

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

Code information: All serial numbers expiration date- 3 years from date of manufacture: NG2095284H, NG2095319H

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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