Boston Scientific is a global leader in medical devices and procedures, 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 procedures and devices that improve patient outcomes.
Boston Scientific devices are generally safe and effective, with rigorous quality control and regulatory compliance. However, like all medical devices, they can have rare complications or malfunctions.
All patients using Boston Scientific medical devices
Check for proper device function, follow manufacturer instructions, and report any unusual symptoms or device issues to your healthcare provider.
Ensure the device is used as directed by the manufacturer.
Monitor for any signs of complications or unusual symptoms.
Report any issues to your healthcare provider immediately.
Yes, Boston Scientific devices undergo rigorous testing and quality control to ensure safety and effectiveness. However, as with all medical devices, there is a small risk of complications.
Contact your healthcare provider immediately and follow their instructions. Do not attempt to self-treat or adjust the device.
Follow the specific instructions provided by your healthcare provider and the device manufacturer. Regular check-ups are typically part of the care plan.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0099-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0099-2026 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.
