Open, Classified

CareLink Clinic, REF: MMT-7350

FDA Recall Z-0594-2026 · Posted 2025-11-25

Recall StatusOpen, Classified

Product CodePHV

Date Initiated2025-10-21

Product Quantity12126

Reason for Recall

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.

Firm 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 return the confirmation form: https://info.medtronicdiabetes.com/carelink-clinic-dashboard-hcp or email form to [email protected] For questions, contact the firm's 24-Hour Technical Support line at 1-800-646-4633, option 9.

Root Cause

Software change control

Distribution Pattern

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 (AU), Sweden (SE), Belgium (BE), Great Britain (GB), Netherlands (NL), Finland (FI), Canada (CA), Germany (DE), Spain (ES), Switzerland (CH), Italy (IT), South Africa (ZA), South Korea (KR), Singapore (SG), New Zealand (NZ), Poland (PL), Israel (IL), Denmark (DK), Norway (NO), Luxembourg (LU), Lithuania (LT), Czech Republic ( CZ), Mexico (MX), Brazil (BR), Colombia (CO), Slovakia (SK), Ireland (IE), Argentina (AR), Greece (GR), Kuwait (KW), Portugal (PT), Iceland (IS), Japan (JP), Turkey (TR), Austria (AT), Qatar (QA), Hong Kong (HK), Chile (CL), Ukraine (UA), Hungary (HU), Estonia (EE), RS, Latvia (LV), Taiwan (TW), Saudia Arabia (SA), Bahrain (BH), Oman (OM), Romania (RO), India (IN), Uruguay (UY), Malaysia (MY), United Arab Emirates (AE), Algeria (DZ), Croatia (HR), France (FR), Russia (RU), Cyprus (CY), Thailand (TH), Egypt (EG), Bosnia and Herzegovina (BA), Libya (LY), and Iraq (IQ)

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.