FDA recall Z-2980-2026

Medtronic MiniMed, Inc. · Class II · device

Product

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

Reason for recall

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.

Distribution

International distribution to the countries of Germany, Denmark, Austria, Netherlands, United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, Northern Ireland.

Key facts

Status
Ongoing
Initiation date
2026-07-13
Report date
2026-08-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northridge, CA, United States

Primary source

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