Recall Z-0594-2026 ยท PHV Continuous Glucose Monitor Retrospective Data Analysis Software
Medtronic MiniMed, Inc.
CareLink Clinic, REF: MMT-7350
| Date | Nov 25, 2025 (initiated Oct 21, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software change control |
| Action | On 10/21/2025, "URGENT MEDICAL DEVICE CORRECTION" notices were emailed to customers informing them of the following: software version 4.2C was released to correct the issues with the data displayed on 24-hour Sensor Glucose Overview graph. If you made individual diabetes treatment recommendations to patients based on the hypoglycemic patterns or on the 30-day sensor glucose data displayed on the 24-hour Sensor Glucose Overview graph with affected software, revisit those recommendations utilizing patients individual CareLink reports, as they were not impacted by this issue. Complete and retu |
| Quantity | 12126 |
| Distribution | Worldwide Distribution: US (nationwide) including states of: TX, NC, MN, CA, VA, ID, WA, GA, MI, MA, OH, IL, IA, CT, FL, PA, NY, TN, AZ, LA, AL, NJ, CO, SC, MS, OR, MT, MD, KS, AK, NH, NE, WY, ND, IN, MO, WI, KY, UT, NV, SD, WV, NM, HI, AR, OK, VT, RI; and OUS (foreign) to countries of: Australia (A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.