Medtronic CareLink Clinic software recall due to insulin calculation defect
Medtronic is recalling CareLink Clinic software version 4.4A because a defect in the Settings Calculator feature may result in incorrect rapid-acting insulin parameters.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source describes a Class II recall for a software defect that can cause incorrect insulin dosing, with potential severity ranging from minor to catastrophic death. The source does not report any specific illnesses, injuries, or deaths.
Plain-English summary
Medtronic MiniMed, Inc. is recalling CareLink Clinic software version 4.4A. The recall is due to a software defect in the Settings Calculator feature where the calculation logic fails to use custom values entered by healthcare professionals for Total Daily Dose or Long-acting insulin. Instead, the calculator uses system-recommended values, resulting in incorrect rapid-acting insulin parameters for Carb Ratio, Insulin Sensitivity Factor, and Max Recommended value.
If these incorrect setting values are input into a patient's MiniMed Go app, the patient could deliver higher or lower insulin doses compared to their actual needs. This could lead to over or under delivery of insulin, with potential severity ranging from minor self-treatable hypoglycemia or hyperglycemia to catastrophic death from severe hypoglycemia.
The affected software was available in the United States between June 4, 2026, and June 8, 2026, with distribution in Kansas. Healthcare professionals and patients should verify their software version and consult Medtronic for guidance on correcting insulin parameters.
The recalled product
- Product
- CareLink Clinic, REF: MMT-7350
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Software
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 2026
- and June 8th
- 2026.
Distribution
Related recalls
Same manufacturer · Medtronic MiniMed, Inc.
See all →- SevereMedtronic MiniMed Go App Recall for Insulin Dose Reminder Failure
FDA (Devices) · 2026-10-28
- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- HighMedtronic MiniMed 640G Insulin Pumps Recalled for Chemical Damage Risk
FDA (Devices) · 2026-08-26
- SevereMedtronic MiniMed 670G Insulin Pumps Recalled Due to Chemical Damage Risk
FDA (Devices) · 2026-08-26
- HighMedtronic MiniMed 780G Insulin Pumps Recalled for Chemical Damage Risk
FDA (Devices) · 2026-08-26
Similar recalls
- HighDiabetes clinic software recalled over incorrect sensor glucose graph data
FDA (Devices) · 2025-12-03
- LowMedtronic CareLink Pro Software Recall for Inaccurate Basal Data Display
FDA (Devices) · 2015-03-11
- HighMedtronic CareLink Diabetes Software Recalled for Data Transfer Errors
FDA (Devices) · 2021-01-20
- HighMedtronic MiniMed 780G software defects may cause insulin delivery inaccuracies
FDA (Devices) · 2026-04-01
- HighMiniMed Go App Recalled Due to Missed Insulin Alerts
FDA (Devices) · 2026-07-29
- ModerateMedtronic Recalls CareLink iPro Software Due to Time Stamp Error
FDA (Devices) · 2016-10-05