Boston Scientific is a leading global medical device company that develops and manufactures innovative medical devices for the treatment of cardiovascular, neurological, and other medical conditions.
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 medical devices for the treatment of cardiovascular, neurological, and other medical conditions.
Boston Scientific is a reputable company with a strong track record in medical device manufacturing. The products are designed to be safe and effective, and they undergo rigorous testing and regulatory compliance processes.
Patients, healthcare providers, and medical facilities
Check for proper labeling, certification, and regulatory compliance (e.g., FDA approval) before using any medical device.
Ensure that the medical device is approved by the relevant regulatory authority (e.g., FDA in the United States).
Verify that the device has been properly labeled with the manufacturer's name, model number, and any necessary warnings or instructions.
Consult with a healthcare professional before using any medical device to ensure it is appropriate for your condition.
Yes, Boston Scientific is a reputable company with a strong track record in medical device manufacturing. The products are designed to be safe and effective, and they undergo rigorous testing and regulatory compliance processes.
Ensure that the medical device is approved by the relevant regulatory authority (e.g., FDA in the United States), verify that it has proper labeling, and consult with a healthcare professional before use.
Boston Scientific produces a wide range of medical devices, including cardiovascular, neurological, and other medical devices for the treatment of various conditions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0098-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0098-2026 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.
