FDA-Device2026-08-26Class IIPROCESSING DEFECT

Medtronic MiniMed 640G insulin pump loaner units recalled for potential malfunction from incompatible cleaning

OTHERNationwide distributionMedical devices

What this means

Certain loaner MiniMed 640G insulin pumps (models MMT-1711 and MMT-1712) were cleaned with products that can damage the pump case or keypad. This damage may allow moisture to enter the pump and cause it to deliver too much or too little insulin, potentially leading to dangerously high or low blood sugar levels.

  • If you received a loaner MiniMed 640G pump, check the model number (MMT-1711 or MMT-1712) and serial number against the FDA recall list.
  • Contact Medtronic MiniMed immediately if your pump's serial number matches the recalled list.
  • Do not use a recalled loaner pump; request a replacement from Medtronic or your healthcare provider.
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The agency's original wording
Hazard

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.

Intended for
Adults
Illnesses reported
None reported
Sold states
International distribution to the countries of Germany, Denmark, Austria, Netherlands, United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, Northern Ireland.
Affected count
16
Manufactured in
18000 Devonshire St, Northridge, CA, United States
Products
MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2980-2026

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