Use cautionMedical device recall · FDA · Published November 12, 2020
Medtronic CareLink Software Recall: Incomplete Insulin Data Risk
Medtronic recalls CareLink Personal Software versions 3.1.5.000 and 3.1.2.000 for diabetes management due to potential incomplete insulin rate data transmission and RF interference during data uploads.
Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at any point from surrounding devices or equipment that may affect the data transfer between the insulin pump and the CareLink Personal or CareLink System Software.
Take action
Contact the company
📍Recalling firmMedtronic Inc.18000 Devonshire St · Northridge, CA 91325-1219
✎ GovInfoNow plain-language explainer
Medtronic is recalling specific versions of its CareLink Personal Software for diabetes management. Incomplete insulin rate data may be transmitted, risking inappropriate therapy changes. This could lead to unsafe insulin dosing if data transfers are interrupted by radio interference. Read more at govinfonow.com/recall/63923-medtronic-carelink-software-recall-incomplete-insulin-data-risk.
“Medtronic CareLink Software Recall: Incomplete Insulin Data Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63923-medtronic-carelink-software-recall-incomplete-insulin-data-risk. Based on FDA recall #Z-0843-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0843-2021%22&limit=1).
The FDA announced on 2020-11-12 that Medtronic Inc. is recalling CareLink Personal and CareLink System Therapy Management Software Tools for diabetes care due to incomplete basal rate information transmission. The hazard stems from radio frequency interference affecting data transfer between insulin pumps and the software. This voluntary Class II recall affects 46,461 systems distributed nationwide in the U.S. and worldwide.
How to tell if you have it
Brand: Medtronic
Products: CareLink Personal Software Therapy Management Software Tool for Diabetes; CareLink System Therapy Management Software Tool for Diabetes
Software Uploader versions: 3.1.5.000, 3.1.2.000
CareLinkTM Personal (MMT-7333) using CareLink Uploader (ACC-7350); UDI (GTIN/UPN): 00763000424121
CareLinkTM system (MMT-7350) using CareLink Uploader (ACC-7350); UDI (GTIN/UPN): 00763000424138
The hazard
Incomplete basal rate information may be transmitted, leading to a potential for inappropriate change in therapy. During data upload, radio frequency interference can occur at any point from surrounding devices or equipment that may affect the data transfer between the insulin pump and the CareLink Personal or CareLink System Software.
Context
GovInfoNow's records show Medtronic, Inc. has 38 other recalls on record since 2017-09-10. Recent brand recalls include a 2026-03-11 Sphere-9 Catheter Recall for risk of ventricular fibrillation and a 2025-12-04 Abre Venous Stent Recall for potential stent migration. Other recent recalls of similar products include a 2026-05-27 MiniMed 780G Insulin Pump Recall for software error causing insulin stoppage and a 2026-02-13 MiniMed 630G Insulin Pump Recall for risk of insulin delivery errors.
How to tell if you have this one
Check your CareLink Personal Software version number. Versions 3.1.5.000 and 3.1.2.000 are affected. The software is used with Medtronic insulin pumps and CareLink Uploader devices.
Brand
Medtronic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your CareLink Personal Software version is 3.1.5.000 or 3.1.2.000.
Update Software
Update to a newer software version if available through Medtronic.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “U.S. Nationwide O.U.S. Worldwide Refer to Associated Documents and uploaded Consignee Lists/Spreadsheets. -Australia New Zealand -Canada -EMEA -Greater China -India -Japan -Latin America -South Korea -Southeast Asia -US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0843-2021 (November 12, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0843-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.