Boston Scientific recalls EMBLEM S-ICD Subcutaneous Electrode Model 3501 due to potential fractures causing therapy delivery failure. Affected patients should contact for guidance.
There is potential for fractures which results in the inability to delivery therapy.
Boston Scientific recalls its EMBLEM S-ICD Subcutaneous Electrode Model 3501 because fractures could prevent the device from delivering life-saving therapy. This is critical for patients with implantable cardioverter defibrillators.
The electrode can fracture, which may prevent the device from delivering necessary therapy. This could lead to life-threatening situations if the device fails to function properly.
Patients with an EMBLEM S-ICD Subcutaneous Electrode Model 3501 implanted device are affected. Those with a history of device fractures or recent device issues are at higher risk.
Check if your device is labeled 'EMBLEM S-ICD Subcutaneous Electrode Model 3501'. The product was sold worldwide starting from the manufacturer's production date.
Immediately stop using the device if you have an EMBLEM S-ICD Subcutaneous Electrode Model 3501.
No, the device has a risk of fracture that could prevent therapy delivery. Do not use it until you contact Boston Scientific.
Check for the model number 'EMBLEM S-ICD Subcutaneous Electrode Model 3501' on your device.
Contact Boston Scientific immediately to get guidance on next steps.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0879-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0879-2021 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.
