Device recall

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

FDA recall source

Recall number

Z-2980-2026

Event id

99374

Status

Ongoing

FDA classification

Class II

Recalling firm

Medtronic MiniMed, Inc.

Report date

Aug 26, 2026

Posted

Aug 18, 2026

Initiated

Jul 13, 2026

Center classification date

Aug 18, 2026

Product code

QFG

Device type

Alternate Controller Enabled Insulin Infusion Pump

Reason

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.

Root cause

Process design

Quantity

16

Code info

Model/UDI-DI/Serial Numbers: MMT-1711/00763000404550/NG2660048H, NG2663343H, NG3015306H; MMT-1712/00763000404567/NG2628486H, NG2758213H, NG2999651H, NG3349198H, NG3351719H, NG2678842H, NG2831821H, NG2831546H, NG2932027H, NG3049657H, NG3033094H, NG2831538H, NG3738739H

Distribution

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

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K251032

Location

Northridge, CA, United States