FDA Medical Device Recalls (openFDA)
Medtronic MiniMed, Inc.: MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;
- Recall number
- Z-2980-2026
- Recalling firm
- Medtronic MiniMed, Inc.
- Product
- MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;
- Status
- Open, Classified
- Initiated
- 2026-07-13
- Posted
- 2026-08-18
- Terminated
- not on file
- 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
- Action
- On 7/13/2026, field safety notices were sent to customers asking them to do the following: 1) Stop using the loaner pump and contact the firm to arrange for loaner pump return. 2) Contact your Healthcare Professional (HCP) to ensure you have access to backup insulin therapy supplies or alternative plans, which may include short- and long-acting insulins, syringes, with dosage instructions from your HCP. 3) Complete and return the customer acknowledgement form. Questions can be directed to the firm's Tech Support: 1-800-646-4633
- Quantity
- 16
- Distribution
- International distribution to the countries of Germany, Denmark, Austria, Netherlands, United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, Northern Ireland.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K251032"]
- PMA numbers
- not on file
- Product code
- QFG
- Firm FEI
- 3003166194
- Firm city
- Northridge
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28