Boston Scientific recalls specific INLIVEN CRT-P pacemakers (models V284, V285, W274, W275) with Extended Life batteries that may initiate Safety Mode, causing temporary system resets. Replacement is required.
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 recalling specific INLIVEN CRT-P pacemakers (models V284, V285, W274, W275) with Extended Life batteries. These devices may enter Safety Mode later in their life, causing temporary system resets. Replacement is required to prevent potential therapy interruptions.
The device's battery may develop high internal impedance over time, causing temporary high-power consumption during telemetry attempts. This can trigger system resets to Safety Mode, which temporarily stops therapy delivery. Replacement is required to maintain proper function.
Patients with the recalled INLIVEN CRT-P pacemakers (models V284, V285, W274, W275) using Extended Life batteries are affected. Those with the specific serial numbers listed in the recall are at risk.
Check your device model (V284, V285, W274, or W275) and Extended Life battery. The recall includes specific serial numbers listed in the official notice. If your device matches these details, it is affected.
Identify your device model (V284, V285, W274, or W275) and confirm it has an Extended Life battery. Check the serial numbers against the list provided in the recall notice.
Reach out to Boston Scientific directly to confirm your device is affected and schedule a replacement.
Yes, replacement is required for affected devices to prevent potential therapy interruptions.
Check your device model (V284, V285, W274, or W275) and Extended Life battery. Compare your serial numbers with the list provided in the official recall notice.
The device may enter Safety Mode, causing temporary system resets. While therapy continues, replacement is required to prevent potential therapy interruptions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2020-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2020-2021 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.
