MiniMed 630G Insulin Pump Recalled for Battery Cap Deterioration
Medtronic MiniMed is recalling the MiniMed 630G insulin pump due to battery cap deterioration that may cause loss of power and function. Approximately 126,558 units distributed in the U.S. and Canada are affected.
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: This is a Class II medical device recall involving an insulin delivery pump—a critical risk-of-harm device where loss of power could prevent essential insulin therapy. Per the rubric, risk-of-harm products where injury has not been reported score at 3 (High).
Plain-English summary
Medtronic MiniMed has recalled the MiniMed 630G insulin pump (model numbers MMT-1515, MMT-1714, MMT-1715, MMT-1755, MMT-1754) due to potential battery cap deterioration. The deterioration may result in an incomplete battery circuit, which could cause the pump to lose power and stop functioning.
The recall affects approximately 126,558 pumps distributed across the United States and Canada. The U.S. Food and Drug Administration has classified this as a Class II recall.
Users with affected devices should contact Medtronic MiniMed or their healthcare provider for information about device replacement or repair options.
The recalled product
- Product
- MiniMed 630G Insulin Pump (U.S. and Canada Version)
- Manufacturer
- Medtronic MiniMed
- Category
- Medical Device — Insulin Pump
- Affected units
- 126,558
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 (4)
- Product Number/CFN (U.S. and Canada Version) MiniMed 630G (MMT-1515
- MMT-1714
- MMT-1715
- MMT-1755
Distribution
Part of a larger recall action
This product is one of 8 recalled by Medtronic MiniMed 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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