The Recall Desk
HighFDA (Devices)·Z-0955-2020·Announced 2020-02-19

Medtronic MiniMed 630G System Recalled for Loose Reservoir Defect

Medtronic is recalling MiniMed 630G Systems with SmartGuard because a broken or missing retainer ring can cause the insulin reservoir to become loose, leading to incorrect insulin delivery.

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 defect that can lead to hypoglycemia or hyperglycemia, which are significant health risks, but the source text does not report specific injuries or fatalities, placing it in the 'High' category for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic Inc. is recalling the MiniMed 630G System with SmartGuard (Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755) for US and Canada versions. The recall affects devices with all serial numbers, excluding those with black retainer rings.

The recall is due to reported incidents of a loose reservoir that can no longer be locked into the pump. This issue occurs when a broken or missing retainer ring prevents a proper lock. If the reservoir is not properly locked, it can result in over or under delivery of insulin, which may cause hypoglycemia or hyperglycemia.

The product was distributed in the United States, Canada, and various international locations including France, Germany, the UK, and Australia. Consumers should check their devices for the presence of a black retainer ring and contact Medtronic for further instructions.

The recalled product

Product
Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only
Manufacturer
Medtronic Inc.
Category
Medical Device — Insulin Pump
Hazard

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 ( excluding devices with black retainer rings)

Distribution

Distributed in 52 states:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Related recalls

Same manufacturer · Medtronic Inc.

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