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 the medical device industry, specializing in cardiovascular, neurovascular, and other medical specialties. They provide innovative solutions for various healthcare applications.
Boston Scientific is a reputable company with a strong track record in medical devices. However, any medical device can pose risks if not used correctly or if there are manufacturing defects.
All users of medical devices
Check for proper usage instructions, regular maintenance, and adherence to safety guidelines. Ensure that devices are certified by relevant regulatory bodies.
Ensure that all medical devices are used according to the manufacturer's instructions.
Regularly check for updates or recalls related to the devices you use.
Contact Boston Scientific's customer support if you have concerns about device safety.
Yes, Boston Scientific is a reputable company with a strong track record in the medical device industry. However, like any company, they follow strict safety protocols to ensure device safety.
You can report device issues through Boston Scientific's customer support or by contacting the relevant regulatory authority.
Common risks include improper use, manufacturing defects, and failure to follow safety guidelines. Boston Scientific provides detailed instructions to minimize these risks.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0101-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0101-2026 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.
