Z-0518-2021Class II

MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only -

Name: Z-0518-2021 MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only -
Creator: Medtronic Inc.
Published: 2020-04-30
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-04-30 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Inc. began a recall of 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... on 2020-04-30. FDA classified it as Class II and gives the reason as "Missing solder battery connection, which could interrupt power of insulin pump". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0518-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-04-30
Posted: 2020-12-02
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.
Product code: N/A
Reason for recall: Missing solder battery connection, which could interrupt power of insulin pump.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: All serial numbers expiration date- 3 years from date of manufacture: NG2095284H, NG2095319H

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0518-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0516-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-09	2020-12-02
Z-0517-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-09	2020-12-02
Z-0518-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-09	2020-12-02

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)