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.
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: 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
- 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
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.
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