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.
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: 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.
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