Boston Scientific is a leading global medical device company specializing in cardiovascular, neurovascular, and surgical products. They provide innovative solutions for healthcare professionals worldwide.
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 and manufactures innovative products for cardiovascular, neurovascular, and surgical procedures. Their products are used by healthcare professionals to improve patient outcomes.
Boston Scientific products are generally safe and effective when used as intended. However, like all medical devices, they require proper training and adherence to manufacturer guidelines to ensure optimal safety and performance.
Healthcare professionals and patients using Boston Scientific medical devices
Check for proper installation, calibration, and maintenance of devices as per manufacturer instructions. Ensure that devices are used within their intended purpose and that healthcare professionals are trained in their use.
Ensure that all Boston Scientific medical devices are used by trained healthcare professionals.
Follow the manufacturer's instructions for proper installation, calibration, and maintenance of devices.
Report any device malfunctions or adverse events to Boston Scientific's customer support or regulatory authorities.
Yes, Boston Scientific products are designed and tested to meet high safety standards. However, like all medical devices, they require proper use and maintenance to ensure safety.
Contact Boston Scientific's customer support or the appropriate regulatory authority in your region to report any device malfunctions or adverse events.
Yes, it is recommended that healthcare professionals receive proper training before using Boston Scientific medical devices to ensure safe and effective use.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0103-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0103-2026 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.
