The Recall Desk
SevereFDA (Devices)·Z-0518-2021·Announced 2020-12-09

Medtronic MiniMed 640G Insulin Pump Recalled for Missing Solder Battery Connection

Medtronic is recalling MiniMed 640G insulin pumps because a missing solder battery connection could interrupt power. The recall covers specific serial numbers distributed in the U.S. and abroad.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for significant injury or serious adverse health consequences (such as interruption of insulin delivery) are rated as Severe (4).

Plain-English summary

Medtronic Inc. is recalling the MiniMed 640G insulin pump, identified by reference/model numbers MMT-1711K, MMT-1752K, and MMT-1752. The recall is due to a missing solder battery connection, which could interrupt the power supply of the insulin pump. This device is indicated for the continuous delivery of insulin for the management of diabetes mellitus in persons requiring insulin.

The recall involves two specific units with serial numbers NG2095284H and NG2095319H. These devices have an expiration date of three years from the date of manufacture. The distribution pattern indicates worldwide distribution, including U.S. nationwide distribution in the state of Maryland, as well as distribution in Canada, the Netherlands, and Norway. The source notes that Model 630G was distributed in Canada, Model 670G in the U.S., and Model 640G outside the U.S. in Australia, Canada, the Netherlands, and Norway.

Consumers with these specific serial numbers should contact Medtronic for instructions on how to proceed. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

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.
Manufacturer
Medtronic Inc.
Category
Medical Device — Insulin Pump
Hazard
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • All serial numbers expiration date- 3 years from date of manufacture: NG2095284H
  • NG2095319H

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Medtronic Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Medtronic Inc.

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Same hazard · power interruption

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