Medtronic, Inc. is recalling approximately 22,091 CareLink SmartSync Patient Connectors (Model 24967) and Device Managers (Model 24967A). These devices use software applications to manage cardiac implants, but a software error in previous versions causes the "Abort" button to stop working during specific induction tests. This defect limits a clinician's ability to cancel the delivery of high-voltage therapy when needed. Medtronic has released updated software versions to correct this issue.
If the "Abort" button fails during a procedure, a clinician may be unable to stop the delivery of a high-voltage shock within the expected window. This could result in the patient receiving unnecessary or unintended high-voltage therapy.
Recall affects prior SmartSync application versions. Corrected versions include 6.5.5, 9.5.2, 4.4.6, 3.5.5, 3.4.2, and 3.7.5 depending on the software model.
Recall affects prior SmartSync application versions. Corrected versions include 6.5.5, 9.5.2, 4.4.6, 3.5.5, 3.4.2, and 3.7.5 depending on the software model.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES ยท Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.