Agency classClass IOur severity:Severe FDA (Devices)·Z-0001-2025·Announced 2024-10-09

MiniMed Insulin Pumps Recalled for Battery Depletion and Delivery Risk

Medtronic MiniMed 630G and 700G insulin pumps may experience battery depletion and device shutdown after physical impact, interrupting insulin delivery in diabetic patients.

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: FDA classification of Class I indicates reasonable probability of serious adverse health consequences. Although no deaths or hospitalizations are explicitly reported in the source, the defect creates risk of device failure during critical insulin delivery.

Plain-English summary

Medtronic MiniMed, Inc. is recalling MiniMed 630G and 700G insulin pumps. The recall covers 24,595 units distributed throughout the United States, territories, and internationally.

Insulin pumps may sustain internal electrical component damage when dropped, bumped, or physically impacted. This damage shortens battery life, reducing the warning time provided by the low battery alarm. The low battery alarm may trigger as little as 2.5 hours before the pump shuts down (or even sooner, according to patient reports), compared to the normal 10-hour warning period. When the pump powers down unexpectedly, insulin delivery stops.

Patients dependent on these pumps face a risk of insufficient insulin delivery, which could result in hyperglycemia or diabetic ketoacidosis (DKA). Replacing the battery does not resolve this issue, as the underlying electrical component damage causes the reduced battery life to persist.

The recalled product

Product: MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851
Manufacturer: Medtronic MiniMed, Inc.
Category: Medical Device — Insulin Pump
Hazard: battery-depletion
device-shutdown
insulin-delivery-interruption
dka-risk
Affected units: 24,595

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 (20)

REF/UDI-DI(GTIN): MMT-1714/00643169782396
00763000253059
MMT-1715/00643169873841
00763000190446
00643169752726
643169873834
00763000317591
00763000316655
763000367053
763000316655
76300031665503
763000190439
763000316631
763000166519
763000072520
76300031665501
763000256807
763000090197
643169656840
763000316686

Distribution

Distributed in 53 states:

Part of a larger recall action

This product is one of 3 recalled by Medtronic MiniMed, 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 →

Same manufacturer · Medtronic MiniMed, Inc.

See all →

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Same hazard · battery depletion