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 solutions and products that improve patient outcomes.
Boston Scientific is a reputable company with a strong safety record. Their products undergo rigorous testing and regulatory compliance to ensure patient safety.
All patients who use Boston Scientific medical devices
Check for proper labeling, certification, and adherence to medical standards on the device.
Ensure the device is labeled with the correct manufacturer information and model number.
Verify that the device has the appropriate medical certifications and regulatory approvals.
Consult with your healthcare provider to confirm the device's compatibility and safety for your specific condition.
Yes, Boston Scientific is a reputable company with a strong safety record and rigorous quality control processes.
Boston Scientific produces a wide range of medical devices, including cardiovascular, neurovascular, and other specialty devices.
Ensure the device is labeled correctly, has the appropriate certifications, and consult with your healthcare provider for specific guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0824-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0824-2025 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.