Boston Scientific is a global leader in medical devices, surgical instruments, and implants. We provide innovative solutions for cardiovascular, neurovascular, and endovascular procedures.
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population
Boston Scientific is a leading global company specializing in medical devices, surgical instruments, and implants. Their products are used in cardiovascular, neurovascular, and endovascular procedures. They are known for innovation and quality in medical technology.
Boston Scientific's products are designed for medical use and are regulated by the FDA. They are not dangerous when used correctly and as intended.
Patients, healthcare professionals, and medical facilities
Check for FDA approval, proper usage instructions, and manufacturer recommendations.
Ensure the product is FDA-approved and within its expiration date.
Follow the manufacturer's instructions for proper use and maintenance.
Report any adverse events to the FDA through their MedWatch program.
Yes, Boston Scientific is a reputable company with a strong track record of safety and quality in medical devices. Their products undergo rigorous testing and are regulated by the FDA.
Boston Scientific produces a wide range of medical devices, including cardiovascular, neurovascular, and endovascular products.
You can report adverse events to the FDA through their MedWatch program or contact Boston Scientific directly.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2017-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2017-2021 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.
