Boston Scientific is a global leader in medical devices and surgical tools. We provide 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 and surgical tools, specializing in cardiovascular, neurovascular, and other medical procedures. They are known for their innovative solutions and high-quality products.
Boston Scientific products are designed to be safe and effective for medical use. They undergo rigorous testing and regulatory approvals to ensure patient safety.
Patients, healthcare professionals, and medical facilities
Check for proper labeling, regulatory approvals (e.g., FDA), and manufacturer recommendations.
Ensure the product is labeled with the correct manufacturer name and model number.
Verify that the product has the appropriate regulatory approvals (e.g., FDA in the United States).
Follow the manufacturer's instructions for use and maintenance.
Boston Scientific is a global leader in medical devices and surgical tools, specializing in cardiovascular, neurovascular, and other medical procedures.
Yes, Boston Scientific products undergo rigorous testing and regulatory approvals to ensure patient safety.
Check the product label for the correct manufacturer name, model number, and regulatory approvals.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0091-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0091-2026 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.
