Boston Scientific is a global leader in medical devices, providing innovative solutions for cardiovascular, neurovascular, and other medical procedures.
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Boston Scientific is a leading global company in medical devices, specializing in cardiovascular, neurovascular, and other medical procedures. They provide innovative solutions for various medical applications.
Boston Scientific devices are generally safe and effective, but like all medical devices, they carry some risk of complications. The company has robust quality control and regulatory compliance processes.
Patients using Boston Scientific medical devices, healthcare professionals, and patients receiving treatments involving Boston Scientific devices.
Check for the latest safety alerts and recalls from Boston Scientific's website or through the FDA. Ensure that your device is up to date with the latest software and firmware updates.
Visit the Boston Scientific website to check for any recent safety alerts or recalls related to your device.
Contact your healthcare provider to confirm that your device is functioning properly and to discuss any concerns.
If you have concerns about a specific device, contact Boston Scientific directly through their customer support or the FDA website.
Yes, Boston Scientific is a reputable company with a strong track record of safety and quality in medical devices. They adhere to strict regulatory standards and have a history of producing reliable products.
If your device is malfunctioning, contact your healthcare provider immediately. They will guide you on the next steps, which may include contacting Boston Scientific's customer support or the FDA.
You can stay updated by signing up for Boston Scientific's email alerts or by checking their website regularly for safety updates. The FDA also provides a database of device recalls and alerts.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0095-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0095-2026 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
