Medtronic MiniMed, Inc.: Device Recall

Recall Details

Recall Number

Z-0958-2026

Classification

Class II

Product Type

Device

Recalling Firm

Medtronic MiniMed, Inc.

Status

Ongoing

Date Initiated

11/13/2025

Location

Northridge, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

8251

Reason for Recall

When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia.

Product Description

InPen App, Model/CFN Number: MMT-8061 (Android Users)

Distribution Pattern

US: IL, AZ, MN, NE, KS, TN, CA, FL, TX, WA, MO, NC, NY, WI, IN, ME, CT, RI, MD, PA, OK, KY, MA, DE, UT, ID, VA, MI, OH, LA, NJ, IA, MT, HI, AR, OR, SC, AL, CO, WY, VT, NV, GA, MS, SD, AK, WV, NH, ND, NM. OUS: Austria, Belgium, Chile, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, South Africa, Spain, Sweden, Switzerland, United Kingdom

Other Recalls by Medtronic MiniMed, Inc.

• Class II: Risk 11/02/2025
  A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.
• Class II: Risk 10/21/2025
  Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.
• Class II: Risk 06/16/2025
  Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact insulin delivery, long-acting insulin dose reminders, or CGM alerts, and users can still use the pen itself to calculate a dose, deliver insulin, record the dose date/time, and view CGM data. This issue was identified during internal testing before release in the US but after release to OUS customers, no complaints or MDRs related to this recall have been reported. Use of the affected device may result hyperglycemia by failing to alert the user and delay treatment of diabetes.
• Class II: Risk 05/07/2025
  The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
• Class II: Risk 03/04/2025
  Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.

View all recalls by Medtronic MiniMed, Inc. →