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 the medical device industry, specializing in cardiovascular, neurovascular, and other medical specialties. They are known for their innovative products and solutions that improve patient outcomes.
Low risk due to rigorous quality control and regulatory compliance standards
All medical professionals and patients using Boston Scientific devices
Check for proper labeling, certification, and adherence to medical guidelines
Verify the device's regulatory status with the FDA or equivalent regulatory body
Ensure the device is used within the intended medical purpose
Follow all manufacturer guidelines for installation and use
Boston Scientific is a global leader in medical devices, providing innovative solutions for cardiovascular, neurovascular, and other medical specialties.
Ensure the device is used within the intended medical purpose, follows all manufacturer guidelines, and has proper regulatory certification.
Yes, Boston Scientific devices are designed and tested to meet high safety standards and are approved by regulatory bodies such as the FDA.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0823-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0823-2025 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.
