Boston Scientific is a global leader in medical devices, providing innovative solutions for cardiovascular, neurovascular, and other medical specialties.
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Boston Scientific is a leading global company in medical devices, specializing in cardiovascular, neurovascular, and other medical specialties. They are known for their innovative products and solutions that improve patient outcomes.
Boston Scientific's products are designed to be safe and effective, with rigorous quality control and regulatory compliance. Any risks are minimal and well-managed through ongoing monitoring and improvements.
Patients, healthcare providers, and medical facilities
Check for proper medical device certifications, such as FDA approval, CE marking, and other regulatory clearances. Ensure the device is used by qualified healthcare professionals in appropriate clinical settings.
Verify the device's regulatory status (e.g., FDA approval, CE marking) before use.
Ensure the device is used by trained healthcare professionals in appropriate clinical settings.
Follow the manufacturer's instructions for use and maintenance.
Yes, Boston Scientific is a highly regulated and reputable medical device manufacturer with a strong commitment to patient safety and quality.
Boston Scientific produces a wide range of medical devices, including cardiovascular, neurovascular, and other specialty devices.
Boston Scientific follows strict quality control processes, regulatory compliance, and continuous monitoring to ensure product safety and effectiveness.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0826-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0826-2025 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.
