Boston Scientific is a global leader in medical devices and solutions, providing innovative products for cardiovascular, neurovascular, and other medical specialties.
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 in medical devices and solutions, specializing in cardiovascular, neurovascular, and other medical specialties. They provide innovative products and solutions for healthcare professionals.
Boston Scientific is a reputable company with a strong track record in medical devices. Their products are designed to be safe and effective, and they follow strict regulatory standards.
Healthcare professionals, patients, and medical facilities
Check for FDA approval, CE marking, and other regulatory certifications for medical devices. Ensure the product is intended for the specific medical application.
Ensure the device has the appropriate regulatory certifications (e.g., FDA approval in the US, CE marking in Europe).
Boston Scientific is a well-established company with a strong reputation in the medical device industry.
Ensure the device meets the intended use and is suitable for the specific medical application.
Yes, Boston Scientific is a global leader in medical devices and solutions with a strong reputation in the healthcare industry.
Boston Scientific products typically have FDA approval in the United States and CE marking in Europe, among other regulatory certifications.
Ensure the product has the appropriate regulatory certifications and is intended for the specific medical application. Always follow the manufacturer's instructions for 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-2015-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2015-2021 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.
