FDA Medical Device Recalls (openFDA)
Medtronic Inc.: MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only - Product Usage: indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
- Recall number
- Z-0518-2021
- Recalling firm
- Medtronic Inc.
- Product
- MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only - Product Usage: indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
- Status
- Open, Classified
- Initiated
- 2020-04-30
- Posted
- not on file
- Terminated
- not on file
- Reason
- Missing solder battery connection, which could interrupt power of insulin pump.
- Root cause
- Nonconforming Material/Component
- Action
- On April 30, 2020, the firm mailed a "Urgent Medical Device Recall" letter to patients. The firm also sent a letter to Health Care Professionals, (HCP) "Urgent Medical Device Recall" that they read this notice and confirm receipt that the customer read and understood the instructions provided in this letter. The letter notified customers that the insulin pumps had an issue on the battery connection that did not meet firm's quality specifications. If power is interrupted on a patients insulin pump, then insulin is suspended, which may lead to hyperglycemia (high blood sugar). There have been no reported complaints from customers as a result of this issue. The firm identified the pump models, serial numbers of the affected devices. In addition to informing patients about the recall, the letter asked patients to do the following: (1) Record current pump settings. Follow the System User Guide to set up new pump that is enclosed in the box. (2) After successfully programming the replacement pump, start using replacement pump. (3) Return affected pump using the included shipping materials. Contact 24-Hour Technical Support at 1-877-585-0166, the instructions provided in this letter. The firm sent a letter to Health Care Professionals, (HCP) "Urgent Medical Device Recall" that they read this notice and confirm receipt that the customer read and understood lead to hyperglycemia (high blood sugar). There have been no reported complaints from customers as a result of this issue. The firm identified the pump models, serial numbers of the affected devices.
- Quantity
- 2
- Distribution
- Worldwide distribution - U.S. Nationwide Distribution in the state of MD and the countries of Canada, Netherlands, Norway. ***Model 630G distributed in Canada and Model 670G distributed in US ***MODEL640G Distributed OUS ONLY*** OUS: Australia, Canada, Netherlands and Norway.
- Lot, serial or model codes
- All serial numbers expiration date- 3 years from date of manufacture: NG2095284H, NG2095319H
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- 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