Medtronic, Inc. has issued a software update for the CareLink SmartSync Device Manager (SmartSync) and SmartSync Patient Connector to fix a critical display error affecting 9,327 units. The software incorrectly showed a pop-up message stating an electrical reset had occurred in a patient's implanted heart device when no such reset had actually happened. While the heart devices themselves remained functional with no loss of settings, the false messages caused confusion that led to 39 reported errors and two instances where patients underwent unnecessary surgery to remove or replace their devices.
The erroneous reset message may cause clinicians to believe an implanted device is malfunctioning or has lost its settings. This confusion can lead to unnecessary and invasive surgical procedures to replace or revise a heart device that is actually working perfectly, exposing patients to standard surgical risks without medical necessity.
Quantity: 3909 units. Software update versions required: 6.5.5, 9.5.2, 4.4.6, 3.5.5, 3.4.2, and 3.7.5.
Quantity: 5418 units. Software update versions required: 6.5.5, 9.5.2, 4.4.6, 3.5.5, 3.4.2, and 3.7.5.
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 · 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.