Medtronic, Inc. has recalled 6 units of the Azure S DR MRI SureScan pacemaker (Product number W3DR01) because the devices may experience a sudden battery power failure without an alarm. This defect can cause the device to reset or stop providing heart pacing therapy entirely. No injuries have been reported to date, but the failure of this life-sustaining device could lead to serious medical emergencies, including cardiac arrest, fainting, or the need for emergency surgical replacement.
The device's battery can fail unexpectedly, leading to a complete loss of heart pacing support which may cause a patient's heart to stop or result in hospitalization. Additionally, patients with affected implants may face surgical risks such as infection or internal bleeding during the necessary replacement procedure.
Recall scope expanded on October 14, 2025, to include implanted devices.
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.