Boston Scientific is a global leader in medical devices, providing innovative solutions for cardiovascular, neurovascular, and other medical specialties.
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 specialties. They are known for their innovative products and solutions that improve patient outcomes.
Boston Scientific's products are generally safe and effective when used as intended. However, like all medical devices, they require proper use and maintenance to ensure safety.
Patients, healthcare providers, and medical professionals
Ensure proper use and maintenance of devices as per manufacturer guidelines, regular check-ups with healthcare providers, and adherence to medical protocols.
Ensure that medical devices are used according to the manufacturer's instructions.
Regularly check with healthcare providers to ensure proper device function and patient safety.
Follow all medical protocols and guidelines for device use and maintenance.
Boston Scientific is a global leader in medical devices, providing innovative solutions for cardiovascular, neurovascular, and other medical specialties.
Yes, Boston Scientific products are generally safe and effective when used as intended. However, they require proper use and maintenance to ensure safety.
Ensure that medical devices are used according to the manufacturer's instructions, regularly check with healthcare providers, and follow all medical protocols and guidelines.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0096-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0096-2026 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.
