Class 2 Device Recall MiniMed 630G Insulin Infusion Pump

• Date Initiated by Firm: April 30, 2020
• Create Date: December 02, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0517-2021
• Recall Event ID: 85711
• PMA Number: P150001
• Product Classification: Automated insulin dosing , threshold suspend - Product Code OZO
• Product: MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage: intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, fourteen years of age and older, requiring insulin.
• Code Information: All serial numbers; expiration date- 3 years from date of manufacture. NG2094617H NG2094618H NG2094623H NG2094625H NG2094627H NG2094628H NG2094629H NG2094631H NG2094632H NG2094634H NG2094635H NG2094636H NG2094637H NG2094638H NG2094639H NG2094640H NG2094641H NG2094642H NG2094644H NG2094645H NG2094646H NG2094647H NG2094648H NG2094649H NG2094650H NG2094651H NG2094652H NG2094653H NG2094654H NG2094655H NG2094656H NG2094657H NG2094658H NG2094659H NG2094660H NG2094661H NG2094662H NG2094663H NG2094664H NG2094668H NG2094669H NG2094670H NG2094695H NG2094696H NG2094697H NG2094698H NG2094699H NG2094700H NG2094702H NG2094704H NG2094705H NG2094707H NG2094711H NG2094712H NG2094714H NG2094718H NG2094719H NG2094724H NG2094726H NG2094728H NG2094730H NG2094732H NG2094733H NG2094735H NG2094737H NG2094739H NG2094740H NG2094743H NG2094767H NG2094769H NG2094771H NG2094772H NG2094773H NG2094774H NG2094775H NG2094776H NG2094777H NG2094779H NG2094781H NG2094783H NG2094789H NG2094795H NG2094799H NG2094800H NG2094801H NG2094803H NG2094805H NG2094806H NG2094807H NG2094809H NG2094820H NG2094822H NG2094824H NG2094825H NG2094826H NG2094827H NG2094828H NG2094829H NG2094830H NG2094832H NG2094834H NG2094836H NG2094846H NG2094847H NG2094849H NG2094851H NG2094853H NG2094855H NG2094856H NG2094858H NG2094860H NG2094862H NG2094863H NG2094864H NG2094865H NG2094866H NG2094875H NG2094877H NG2094879H NG2094881H NG2094883H NG2094884H NG2094886H NG2094890H NG2094892H NG2094903H NG2094905H NG2094906H NG2094908H NG2094910H NG2094912H NG2094914H NG2094916H NG2094919H NG2094921H NG2094923H NG2094925H NG2094926H NG2094929H NG2094930H NG2094931H NG2094932H NG2094933H NG2094934H NG2094936H NG2094937H NG2094939H NG2094941H NG2094945H NG2094947H NG2094950H NG2094964H NG2094966H NG2094968H NG2094972H NG2094975H NG2095028H NG2095034H NG2095036H NG2095038H NG2095039H NG2095046H NG2095048H NG2095050H NG2095052H NG2095054H NG2095056H NG2095058H NG2095060H NG2095065H NG2095067H NG2095069H NG2095071H NG2095073H NG2095075H NG2095079H NG2095083H NG2095085H NG2095087H NG2095091H NG2095096H NG2095097H NG2095099H NG2095103H NG2095105H NG2095107H NG2095114H NG2095121H NG2095122H NG2095124H NG2095127H NG2095128H NG2095129H NG2095130H NG2095131H NG2095132H NG2095133H NG2095134H NG2095135H NG2095136H NG2095138H NG2095139H NG2095141H NG2095143H NG2095144H NG2095148H
• 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: 206
• 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 = OZO and Original Applicant = MEDTRONIC MINIMED