—#181608

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.

FDA product code: N/A
Affected lot / code info: All serial numbers expiration date- 3 years from date of manufacture: NG2095284H, NG2095319H

Why it was recalled

Missing solder battery connection, which could interrupt power of insulin pump.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc.
Address: 18000 Devonshire St, Northridge, California 91325-1219

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-04-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181608. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.