MiniMed 640G Insulin Pumps Recalled for Battery Cap Deterioration
Medtronic has recalled approximately 323,417 MiniMed 640G insulin pumps due to battery cap deterioration that may cause loss of power and functionality. Patients should contact Medtronic or their healthcare provider immediately.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: FDA Class II medical device recall affecting a critical care product. The hazard is theoretical as stated in the source (no illnesses or injuries reported), but the risk is significant: insulin pump failure could deny diabetic patients their life-sustaining medication. Meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic MiniMed is recalling the MiniMed 640G insulin pump (O.U.S. version) due to battery cap deterioration that may cause an incomplete battery circuit. This could result in loss of power and the pump's inability to deliver insulin.
The recall affects approximately 323,417 pumps distributed across the United States. The affected product numbers are MMT-1511, MMT-1512, MMT-1711, MMT-1712, MMT-1751, and MMT-1752.
Patients using one of these pumps should contact Medtronic or their healthcare provider immediately. Specific serial numbers associated with the affected devices have been identified in the recall notice.
The recalled product
- Product
- MiniMed 640G Insulin Pump (O.U.S. Version)
- Manufacturer
- Medtronic MiniMed
- Category
- Medical Device — Insulin Pump
- Affected units
- 323,417
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 (6)
- Product Number/CFN (O.U.S. Version) MiniMed 640G (MMT-1511
- MMT-1512
- MMT-1711
- MMT-1712
- MMT-1725 (Pre Prod only)
- MMT-1751
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.
See all 8 products in this recall →Related recalls
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