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 are known for their innovative solutions and high-quality products.
Boston Scientific devices are generally safe and effective, but like all medical devices, they carry a small risk of complications. The company has a strong safety record and rigorous quality control processes.
Patients using Boston Scientific medical devices, healthcare professionals, and patients receiving treatments involving these devices
Check for any recalls or warnings issued by Boston Scientific for specific devices. Consult with your healthcare provider about the safety of your device.
Check the Boston Scientific website for any recalls or warnings related to your specific device model.
Contact your healthcare provider to discuss the safety of your device and any potential risks.
If you have concerns, report them to the FDA or your local regulatory authority.
Yes, Boston Scientific devices are generally safe and effective. However, like all medical devices, they carry a small risk of complications. The company has a strong safety record and rigorous quality control processes.
You can check for recalls on the Boston Scientific website or by contacting your healthcare provider. The FDA also maintains a database of device recalls.
If you have a problem with your device, contact your healthcare provider immediately. They will guide you on the next steps, which may include reporting the issue to the FDA or Boston Scientific.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0084-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0084-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
