Boston Scientific is a leading global medical device company that develops, manufactures, and distributes innovative medical devices for the treatment of cardiovascular, neurovascular, and other conditions.
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 medical device company that develops, manufactures, and distributes innovative medical devices for the treatment of cardiovascular, neurovascular, and other conditions.
Boston Scientific is a reputable medical device manufacturer with a strong safety record. Their devices are subject to rigorous regulatory oversight and quality control processes.
All users of Boston Scientific medical devices
Check for proper labeling, certification, and compliance with regulatory standards such as FDA, CE, and ISO.
Ensure that the medical device is properly labeled with the manufacturer's name, model number, and regulatory certifications.
Verify that the device has been approved by relevant regulatory bodies such as the FDA (United States), CE (Europe), or other international regulatory authorities.
Check for any recalls or warnings issued by the manufacturer or regulatory authorities for the specific device model.
Consult with healthcare professionals or the manufacturer for additional information about device safety and proper usage.
Yes, Boston Scientific is a reputable medical device manufacturer with a strong safety record. Their devices are subject to rigorous regulatory oversight and quality control processes.
Ensure that the device is properly labeled with the manufacturer's name, model number, and regulatory certifications. Verify that the device has been approved by relevant regulatory bodies such as the FDA, CE, or other international regulatory authorities.
Boston Scientific regularly monitors and addresses any potential safety issues. If there are recalls, they will be communicated through official channels such as their website, regulatory authorities, or direct communication with healthcare providers.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2018-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2018-2021 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.
