FDA Medical Device Recalls (openFDA)
Medtronic MiniMed, Inc.: InPen App, Model/CFN Number: MMT-8061 (Android Users)
- Recall number
- Z-0958-2026
- Recalling firm
- Medtronic MiniMed, Inc.
- Product
- InPen App, Model/CFN Number: MMT-8061 (Android Users)
- Status
- Open, Classified
- Initiated
- 2025-11-13
- Posted
- 2025-12-18
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Software Design Change
- Action
- On 11/13/2025, correction notices were emailed to customers who were asked to update to version 8.0.1 or higher as soon as possible to resolve this issue. 1.Verify your app version: -On the home screen, navigate to the Settings menu (lower right corner). - Select Help and Support. - Note the App Version displayed. 2. If you are running versions 8.0.0, update to the latest version 8.0.1 or higher via the Google Play Store: - Open the Google Play Store. - Tap your profile icon at the top of the screen, then select Manage apps & device. - Tap Updates available or search for the InPen app. - Tap Update next to the InPen app icon. Electronically acknowledge that you have read and understand this notification and have followed the actions listed For questions, contact the firm's 24-Hour Technical Support line at 1-800-646-4633, option #1. The Customer Confirmation Form can also be emailed to the firm at rs.safetyinformation@medtronic.com
- Quantity
- 8251
- Distribution
- 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
- Lot, serial or model codes
- Software Versions: 7.5.0, 7.5.1, and 8.0.0. UDI-DI: 00763000974596
- 510(k) numbers
- ["K242775"]
- PMA numbers
- not on file
- Product code
- NDC
- Firm FEI
- 3003166194
- Firm city
- Northridge
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28