The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly…"

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 →

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