The Recall Desk
HighFDA (Devices)·Z-0517-2021·Announced 2020-12-09

Medtronic MiniMed 630G Insulin Pump Recalled for Battery Connection Defect

Medtronic is recalling 206 MiniMed 630G insulin pumps due to a missing solder battery connection that could interrupt power.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a power interruption could lead to a risk of harm (insulin delivery failure), but no injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Medtronic Inc. is recalling 206 units of the MiniMed 630G with SmartGuard insulin pump (Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K). The recall is due to a missing solder battery connection, which could interrupt the power of the insulin pump.

The affected devices were distributed worldwide, including in the United States (specifically Maryland), Canada, the Netherlands, and Norway. The source text notes that Model 630G was distributed in Canada, Model 670G in the US, and Model 640G outside the US only, though the specific model for the recalled units is identified as 630G in the product name.

Consumers should check their device serial numbers against the list provided by the manufacturer or the FDA. If a device is affected, users should contact Medtronic for instructions on how to proceed, as the defect may cause the pump to stop delivering insulin.

The recalled product

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
Manufacturer
Medtronic Inc.
Category
Medical Device — Insulin Pump
Hazard
Affected units
206

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 (1)

  • All serial numbers

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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