Boston Scientific is a leading global medical device company that develops, manufactures, and distributes innovative medical devices for cardiovascular, neurovascular, and other therapeutic applications.
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 medical device company that develops, manufactures, and distributes innovative medical devices for cardiovascular, neurovascular, and other therapeutic applications.
Boston Scientific is a reputable medical device manufacturer with a strong track record of safety and quality. The company adheres to strict regulatory standards and conducts rigorous testing to ensure the safety of their products. There are no known safety issues with Boston Scientific products.
All users of Boston Scientific medical devices
Check for the latest product updates and safety alerts from Boston Scientific's official website or regulatory bodies like the FDA.
Visit Boston Scientific's official website to review their product safety information and recalls.
Check the FDA website for any product recalls or safety alerts related to Boston Scientific devices.
Contact Boston Scientific's customer support for specific product-related concerns.
Yes, Boston Scientific is a reputable medical device manufacturer with a strong track record of safety and quality. The company adheres to strict regulatory standards and conducts rigorous testing to ensure the safety of their products.
If you have a Boston Scientific device that is malfunctioning, contact Boston Scientific's customer support or the FDA for assistance.
Boston Scientific regularly monitors product safety and reports recalls through the FDA. Check the FDA website for the latest information.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0097-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0097-2026 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.
