Boston Scientific is a leading global medical device company that develops and manufactures innovative medical devices for the treatment of cardiovascular, neurovascular, and other medical 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 and manufactures innovative medical devices for the treatment of cardiovascular, neurovascular, and other medical conditions.
Boston Scientific is a reputable company with a strong track record in medical device manufacturing. Their products are subject to rigorous quality control and regulatory oversight. The risk of harm from their devices is generally low due to extensive testing and compliance with international standards.
Patients, healthcare professionals, and medical device users
Ensure that the medical device is approved by the relevant regulatory authority (e.g., FDA in the United States) and that it has been tested for safety and efficacy.
Verify that the device has been approved by the relevant regulatory authority (e.g., FDA in the United States).
Examine the safety documentation provided by the manufacturer to ensure the device meets safety standards.
Discuss any concerns with your healthcare provider to ensure the device is appropriate for your condition.
Yes, Boston Scientific is a reputable company with a strong track record in medical device manufacturing. Their products are subject to rigorous quality control and regulatory oversight.
Ensure that the device has been approved by the relevant regulatory authority (e.g., FDA in the United States) and that it has been tested for safety and efficacy.
Consult with your healthcare provider or contact Boston Scientific's customer support for assistance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2016-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2016-2021 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.
