Boston Scientific recalls SQ-RX Pulse Generator (Model 1010) for accelerated battery depletion due to internal malfunctions, potentially shortening replacement intervals. Affected patients should contact for guidance.
Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.
Boston Scientific is recalling the SQ-RX Pulse Generator (Model 1010) as it can deplete faster than expected due to internal battery issues, which may require more frequent replacements. This could lead to gaps in life-saving defibrillation therapy if the device fails.
The device has internal battery malfunctions that cause it to deplete faster than normal, leading to a shorter replacement interval. This could mean the device stops working before the scheduled replacement time, risking gaps in life-saving defibrillation therapy.
Patients with a Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) system using the SQ-RX Pulse Generator (Model 1010) are affected. Those with the device are most at risk due to potential battery failure.
Check if your S-ICD system uses the SQ-RX Pulse Generator (Model 1010). The device is part of a life-saving system for ventricular arrhythmias.
Reach out to Boston Scientific for guidance on next steps regarding your device.
The device may deplete faster than expected due to internal battery issues, which could lead to more frequent replacements. However, it is not immediately dangerous in normal use.
Check if your S-ICD system uses the SQ-RX Pulse Generator (Model 1010).
Contact Boston Scientific for guidance on next steps regarding your device.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0474-2019 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0474-2019 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.
