Class 2 Device Recall MiniMed 670G Insulin Infusion Pump

• Date Initiated by Firm: April 30, 2020
• Create Date: December 02, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0516-2021
• Recall Event ID: 85711
• PMA Number: P160017
• Product Classification: Automated insulin dosing device system, single hormonal control - Product Code OZP
• Product: MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and detecting possible low and high glucose episodes. When using a sensor and transmitter, the pump displays continuous sensor glucose values and stores this data so that it can be analyzed to track patterns and improve diabetes management. This data can be uploaded to a computer for analysis of historical glucose values.
• Code Information: All serial numbers expiration date- 3 years from date of manufacture. NG2093124H NG2093129H NG2093154H NG2093164H NG2093187H NG2093188H NG2093193H NG2093219H NG2093228H NG2093235H NG2093253H NG2093254H NG2093257H NG2093258H NG2093265H NG2093269H NG2093288H NG2093303H NG2093307H NG2093345H NG2093349H NG2093362H NG2093377H NG2093397H NG2093423H NG2093425H NG2093426H NG2093463H NG2093466H NG2093476H NG2093478H NG2093521H NG2093558H NG2093564H NG2093577H NG2093608H NG2093624H NG2093670H NG2093673H NG2093675H NG2093693H NG2093697H NG2093707H NG2093708H NG2093711H NG2093712H NG2093734H NG2093743H NG2093764H NG2093777H NG2093825H NG2093835H NG2093844H NG2093860H NG2093869H NG2093871H NG2093889H NG2093891H NG2093894H NG2093922H NG2093932H NG2093969H NG2093973H NG2093981H NG2094026H NG2094030H NG2094035H NG2094043H NG2094044H NG2094048H NG2094053H NG2094075H NG2094082H NG2094231H NG2094234H NG2094235H NG2094237H NG2094239H NG2094241H NG2094242H NG2094245H NG2094248H NG2094249H NG2094250H NG2094254H NG2094256H NG2094258H NG2094259H NG2094262H NG2094263H NG2094266H NG2094272H NG2094274H NG2094276H NG2094281H NG2094282H NG2094286H NG2094288H NG2094289H NG2094290H NG2094292H NG2094294H NG2094295H NG2094297H NG2094302H NG2094303H NG2094304H NG2094306H NG2094307H NG2094313H NG2094315H NG2094322H NG2094326H NG2094329H NG2094330H NG2094338H NG2094341H NG2094342H NG2094344H NG2094347H NG2094349H NG2094351H NG2094352H NG2094355H NG2094358H NG2094360H NG2094362H NG2094363H NG2094364H NG2094366H NG2094368H NG2094376H NG2094380H NG2094382H NG2094389H NG2094390H NG2094393H NG2094398H NG2094401H NG2094402H NG2094403H NG2094406H NG2094408H NG2094419H NG2094424H NG2094428H NG2094430H NG2094433H NG2094434H NG2094444H NG2094447H NG2094450H NG2094454H NG2094458H NG2094460H NG2094461H NG2094464H NG2094466H NG2094470H NG2094471H NG2094477H NG2094479H NG2094485H NG2094489H NG2094490H NG2094493H NG2094496H NG2094497H NG2094499H NG2094509H NG2094517H NG2094519H NG2094527H NG2094528H NG2094529H NG2094533H NG2094534H NG2094536H NG2094537H NG2094555H NG2094585H NG2094594H NG2111643H -U.S.
• Recalling Firm/ Manufacturer: Medtronic Inc.; 18000 Devonshire St; Northridge CA 91325-1219
• For Additional Information Contact: Pamela Reese; 818-576-4700
• Manufacturer Reason for Recall: Missing solder battery connection, which could interrupt power of insulin pump.
• FDA Determined 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: 391
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = OZP and Original Applicant = MEDTRONIC MINIMED, INC.