Medtronic MiniMed 670G Insulin Pumps Recalled Due to Chemical Damage Risk
Medtronic is recalling seven MiniMed 670G insulin pumps because chemical cleaning may have damaged the devices, risking 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 recall is classified as FDA Class II and involves a medical device defect that can cause significant injury, including diabetic ketoacidosis, which aligns with the 'Severe' criteria for significant injury reports or high-risk device failures.
Plain-English summary
Medtronic MiniMed, Inc. is recalling seven units of the MiniMed 670G Insulin Pump, models MMT-1781 and MMT-1782. The recall is due to a risk that loaner insulin pumps were cleaned with chemically incompatible products. This exposure could damage the pump case or keypad, allowing moisture to enter the device.
The potential damage to the pump's integrity may result in the over-delivery or under-delivery of insulin. Such malfunctions could lead to serious health consequences for patients, including hypoglycemia, hyperglycemia, or diabetic ketoacidosis.
The affected units were distributed internationally to Germany, Denmark, Austria, the Netherlands, the United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, and Northern Ireland. Specific serial numbers are listed in the agency's recall record. Consumers with these specific devices should contact Medtronic MiniMed, Inc. for instructions on how to proceed.
The recalled product
- Product
- MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Insulin Pump
- Affected units
- 7
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)
- Model/UDI-DI Serial Numbers: MMT-1781/00763000404536/NG2665223H
- NG2748200H
- NG2748664H
- NG2755237H
- NG2716176H
- NG3547582H. MMT-1782/00763000404543/NG2768190H
Distribution
Distribution scope not specified by the agency.
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