Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall CareLink Clinic Software Version 4.4A

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall CareLink Clinic Software Version 4.4Asee related information
Date Initiated by FirmSeptember 11, 2026
Date PostedOctober 21, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0203-2027
Recall Event ID 99765
Product Classification Continuous glucose monitor retrospective data analysis software - Product Code PHV
ProductCareLink Clinic, REF: MMT-7350
Code Information UDI-DI: 0763000B00008748K. Software Versions: 4.4A Software Available: US: Between June 4th, 2026, and June 8th, 2026.
FEI Number 3003166194
Recalling Firm/
Manufacturer		 Medtronic MiniMed, Inc.
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information ContactAshley Patterson
800-646-4633
Manufacturer Reason
for Recall		CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by healthcare professionals (HCPs) for Total Daily Dose (TDD) or Long-acting insulin when calculating the Carb Ratio, Insulin Sensitivity Factor (ISF), and Max Recommended value for Rapid-acting insulin. Instead, the calculator continues to use the system-recommended values, resulting in incorrect rapid-acting insulin parameters. If an HCP or patient inputs these incorrect setting values into the patient's MiniMed Go app, the patient could deliver higher or lower insulin doses compared to their insulin needs, potentially leading to over/under delivery of insulin with a severity ranging from Catastrophic (death from severe hypoglycemia) to Minor (self-treatable hypoglycemia/hyperglycemia).
FDA Determined
Cause 2		Software design
ActionOn 9/11/2026, correction notices were mailed to the health care professional, and customer asking them to do the following: The Customer was asked to do the following: Immediately contact your Healthcare Provider (HCP) to confirm your insulin settings values. Complete and return the confirmation form by visiting https://info.medtronicdiabetes.com/FA1587 The health care professional was asked to do the following: If you provided diabetes treatment recommendations to patients based on custom Total Daily Dose(TDD) or long-acting insulin values entered into the CareLin Clinic Settings Calculator between: June 04, 2026, to June 08, 2026, please revisit those recommendations utilizing patients' individual CareLink reports. Continue to follow up with those patients pursuant to your standard of care. If you have further questions or need assistance, please call the firm's 24-Hour Technical Support line at 1-800-646-4633, option 1.
Quantity in Commerce1
DistributionUS Nationwide distribution in the state of KS.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-