Boston Scientific is a leading global medical device company specializing in cardiovascular, neurovascular, and endovascular solutions. We provide innovative products for the treatment of heart disease, stroke, and other conditions.
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 medical device company that develops and manufactures innovative products for cardiovascular, neurovascular, and endovascular procedures. Their products are used in the treatment of heart disease, stroke, and other conditions.
Boston Scientific products are designed for medical use and are not intended for consumer use. They are regulated by the FDA and are used under the supervision of trained medical professionals.
All patients who require cardiovascular, neurovascular, or endovascular procedures
Check for FDA approval, product labels, and instructions for use. Ensure the product is prescribed by a licensed medical professional.
Verify that the product is approved by the FDA or equivalent regulatory body in your country.
Ensure that the product is prescribed by a licensed medical professional.
Follow the instructions for use provided by the manufacturer.
Yes, Boston Scientific is a reputable company with a strong track record of producing safe and effective medical devices. They adhere to strict quality control standards and are regulated by the FDA.
All Boston Scientific products are designed and manufactured to meet FDA standards. You can check for FDA approval on the product label or website.
No, Boston Scientific products are medical devices and require a prescription from a licensed medical professional. They are not intended for consumer 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-0822-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0822-2025 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.
