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FDA · Medical devices ·

MiniMed 640G Insulin Pump recall

Medtronic MiniMed, Inc. recalled MiniMed 640G Insulin Pump on August 26, 2026 because of loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis. It was sold in International distribution to the countries of Germany, Denmark, Austria, Netherlands, Un….

Why it was recalled

Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

What's recalled

MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;

Quantity: 16

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Medtronic MiniMed, Inc., Northridge, CA
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
International distribution to the countries of Germany, Denmark, Austria, Netherlands, Un…
International distribution to the countries of Germany, Denmark, Austria, Netherlands, United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, Northern Ireland.
Status
Ongoing
Recall number
Z-2980-2026
Source
U.S. Food and Drug Administration

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