Medtronic MiniMed 640G Insulin Pump Recall for Loose Reservoir Risk
Medtronic is recalling specific 640G insulin pumps due to a loose reservoir that may cause incorrect insulin delivery.
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: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric. Additionally, the defect poses a risk of significant injury through hypoglycemia or hyperglycemia.
Plain-English summary
Medtronic Inc. is recalling specific models of the MiniMed 640G Insulin Infusion Pump. The affected units are identified by reference numbers MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, and MMT-1752. The recall applies to all serial numbers, excluding devices equipped with black retainer rings. The source text explicitly notes that these specific units were not distributed within the United States, though the distribution pattern lists numerous US states and international countries.
The recall is due to reported incidents where the insulin reservoir becomes loose and can no longer be locked into the pump. This issue is caused by a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly secured, it can lead to the over-delivery or under-delivery of insulin.
Incorrect insulin delivery can result in hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar). Users of these specific pump models should contact Medtronic for instructions on how to proceed, as the device may not function safely if the reservoir is not locked correctly.
The recalled product
- Product
- Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, and MMT-1752 *Not for US Distribution
- Manufacturer
- Medtronic Inc.
- Category
- Medical Device — Insulin Pump
Distribution
Part of a larger recall action
This product is one of 4 recalled by Medtronic 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 4 products in this recall →Related recalls
Same manufacturer · Medtronic Inc.
See all →- HighMedtronic Sphere-9 Catheter may cause ventricular fibrillation with Biotronik ICDs
FDA (Devices) · 2026-05-06
- HighVenous stents recalled over a nitinol anomaly that reduces deployed diameter
FDA (Devices) · 2026-01-21
- ModerateKidney tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- HighSmartSync Patient Connector limited the window to abort high voltage therapy
FDA (Devices) · 2025-07-30
- HighCareLink SmartSync limited the window to abort a high voltage therapy
FDA (Devices) · 2025-07-30
Same hazard · insulin dosing error
See all →- HighMedtronic MiniMed 640G Insulin Pumps Recalled for Chemical Damage Risk
FDA (Devices) · 2026-08-26
- SevereMedtronic MiniMed 670G Insulin Pumps Recalled Due to Chemical Damage Risk
FDA (Devices) · 2026-08-26
- HighMedtronic MiniMed 780G Insulin Pumps Recalled for Chemical Damage Risk
FDA (Devices) · 2026-08-26
- HighMedical Device Recall: Guardian 4 Glucose Sensor Manufacturing Defect
FDA (Devices) · 2024-02-14
- SevereJelco Insulin Syringe Graduation Markings Recalled for Skew Defect
FDA (Devices) · 2021-06-16
Similar recalls
- HighMedtronic MiniMed 640G Insulin Pumps Recalled for Motor Malfunction
FDA (Devices) · 2015-12-23
- HighMedtronic MiniMed 640G Insulin Pumps Recalled for Chemical Damage Risk
FDA (Devices) · 2026-08-26
- HighMedtronic Recalls MiniMed 640G Insulin Pumps Due to Keypad Malfunction
FDA (Devices) · 2017-06-28
- HighMiniMed 640G insulin pump delivery varies with pump height changes
FDA (Devices) · 2026-04-08
- HighMiniMed 630G insulin pump delivery varies with pump height changes
FDA (Devices) · 2026-04-08
- HighMedtronic MiniMed 620G Insulin Pump Recall for Motor Malfunction
FDA (Devices) · 2015-12-23