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.
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: 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
- Hazard
- battery-circuit-failure
- power-loss
- device-malfunction
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
Distributed in 53 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- PR
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- VI
- VT
- WA
- WI
- WV
- WY
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