Boston Scientific EMBLEM S-ICD Subcutaneous Electrode Model 350: Fracture Risk
Boston Scientific recalls EMBLEM S-ICD Subcutaneous Electrode Model 3501 due to potential fractures causing therapy delivery failure. Affected patients should contact for guidance.
Stop using this now
There is potential for fractures which results in the inability to delivery therapy.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/63915-boston-scientific-emblem-s-icd-subcutaneous-electrode-model-350-fracture.
Source Summary by GovInfoNow · govinfonow.com/recall/63915-boston-scientific-emblem-s-icd-subcutaneous-electrode-model-350-fracture · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0879-2021
Cite this page
“Boston Scientific EMBLEM S-ICD Subcutaneous Electrode Model 350: Fracture Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63915-boston-scientific-emblem-s-icd-subcutaneous-electrode-model-350-fracture. Based on FDA recall #Z-0879-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0879-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Boston Scientific- Category
Medical device
What to do — step by step
Stop Using It Now
Immediately stop using the device if you have an EMBLEM S-ICD Subcutaneous Electrode Model 3501.
How this recall unfolded
Recall timeline
FDA terminated this recall 3.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0879-2021 (November 13, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0879-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.