Boston Scientific Recalls Accolade Pacemaker Devices
By Stephanie Brown HealthDay Reporter
TUESDAY, Feb. 25, 2025 -- Boston Scientific has issued a recall of Accolade pacemaker devices, according to a safety communication from the U.S. Food and Drug Administration.
The Accolade devices under recall include the Accolade, Proponent, Essentio, and Altrua 2 Standard Life and Extended Life pacemakers and the Visionist and Valitude cardiac resynchronization therapy pacemakers.
The devices are being recalled due to an increased risk for permanently entering Safety Mode. Safety Mode has limited functionality and is associated with the pacemaker being unable to properly regulate the heart's rhythm and rate in some patients. Devices that enter Safety Mode need to be replaced.
Due to a manufacturing issue, the battery underpowers the device and causes the device to permanently enter Safety Mode. The FDA is working with the manufacturer to assess the risk for this issue in all Accolade pacemaker devices and to pinpoint additional mitigation strategies as needed.
Serious adverse health consequences, including slow heartbeats, fainting, and death, may be caused by the recalled devices. So far, 832 injuries and two deaths have been reported.
Physicians and patients should work together to monitor Accolade pacemaker devices. For patients at high risk for harm associated with interrupted pacing that may occur with Safety Mode, the device should be immediately replaced. For other patients, nonurgent replacement is recommended. Any problems encountered with Accolade pacemaker devices should be reported to the FDA.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2025 HealthDay. All rights reserved.
Posted February 2025
Read this next
Antidepressants Linked To Sudden Cardiac Death
FRIDAY, April 4, 2025 -- Antidepressants appear to increase people’s risk of sudden cardiac death, a new study says. People taking the mood meds are more likely to die...
Cardiac Arrest Deaths During Marathons Down By Half
TUESDAY, April 1, 2025 -- A marathon can be a daunting challenge, particularly for folks worried their hearts can’t stand the strain of running 26.2 miles. But these events...
Prompt CPR Saves Lives, Regardless Of Who Performs It
TUESDAY, March 18, 2025 -- It doesn’t matter if CPR is performed by a doctor, a paramedic or an unskilled, unpracticed passerby -- when performed promptly, it will increase...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.