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Medtronic MiniMed, Inc.: CareLink Clinic, REF: MMT-7350

Medical DevicesSource: FDA (device) · Date: 2025-12-03

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medtronic MiniMed, Inc.
Product
CareLink Clinic, REF: MMT-7350
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
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)
Recall initiated
2025-10-21
Code info
UDI-DI: 0763000B00008748K. Software Versions: 4.2B Software Available: US: Between September 4th, 2025, and October 3rd, 2025. OUS: Between September 11th, 2025, and October 4th, 2025. US (Clinical): Between August 21st, 2025, and October 3rd, 2025. OUS (Clinical): Between August 21st, 2025, and October 4th, 2025.
Product quantity
12126
Voluntary mandated
Voluntary: Firm initiated
City
Northridge
State
CA
Country
United States
Event id
97873
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