FDA Medical Device Recalls (openFDA)
Medtronic MiniMed, Inc.: CareLink Clinic, REF: MMT-7350
- Recall number
- Z-0594-2026
- Recalling firm
- Medtronic MiniMed, Inc.
- Product
- CareLink Clinic, REF: MMT-7350
- Status
- Open, Classified
- Initiated
- 2025-10-21
- Posted
- 2025-11-25
- Terminated
- not on file
- 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 return the confirmation form: https://info.medtronicdiabetes.com/carelink-clinic-dashboard-hcp or email form to rs.safetyinformation@medtronic.com For questions, contact the firm's 24-Hour Technical Support line at 1-800-646-4633, option 9.
- 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 (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)
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PHV
- 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