Class 2 Device Recall MiniMed" 670G System

• Date Initiated by Firm: July 13, 2026
• Date Posted: August 18, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2981-2026
• Recall Event ID: 99374
• PMA Number: P160017
• Product Classification: Automated insulin dosing device system, single hormonal control - Product Code OZP
• Product: MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782
• Code Information: Model/UDI-DI Serial Numbers: MMT-1781/00763000404536/NG2665223H, NG2748200H, NG2748664H, NG2755237H, NG2716176H, NG3547582H. MMT-1782/00763000404543/NG2768190H
• FEI Number: 3003166194
• Recalling Firm/ Manufacturer: Medtronic MiniMed, Inc.; 18000 Devonshire St; Northridge CA 91325-1219
• For Additional Information Contact: Ashley Patterson; 800-646-4633
• Manufacturer Reason for Recall: Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.
• FDA Determined Cause: Process design
• Action: On 7/13/2026, field safety notices were sent to customers asking them to do the following: 1) Stop using the loaner pump and contact the firm to arrange for loaner pump return. 2) Contact your Healthcare Professional (HCP) to ensure you have access to backup insulin therapy supplies or alternative plans, which may include short- and long-acting insulins, syringes, with dosage instructions from your HCP. 3) Complete and return the customer acknowledgement form. Questions can be directed to the firm's Tech Support: 1-800-646-4633
• Quantity in Commerce: 7
• Distribution: International distribution to the countries of Germany, Denmark, Austria, Netherlands, United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, Northern Ireland.
• 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