Boston Scientific Recalls Emblem S-ICD Subcutaneous Electrodes Due to Fracture Risk
Boston Scientific is recalling Emblem S-ICD Subcutaneous Electrodes because fractures may prevent the device from delivering therapy.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
Boston Scientific Corporation is recalling the Emblem S-ICD Subcutaneous Electrode Model 3501, a component of an implantable cardioverter defibrillator (ICD). The recall involves 47,000 units that were distributed worldwide, including the United States, US territories, Canada, Latin America, Europe, the Middle East, Africa, and the Asia-Pacific region.
The recall is being issued because there is a potential for the electrodes to fracture. If a fracture occurs, the device may be unable to deliver therapy. All serialized Emblem Subcutaneous Electrodes Model 3501 manufactured and distributed are subject to this worldwide advisory communication.
Patients with these devices should contact their healthcare provider for guidance on next steps. The FDA has classified this recall as Class I, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 47,000
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · device fracture
See all →- HighHowmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23
- SevereHowmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Orthopaedic Implant Components Due to Material Aging
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Orthopaedic Implants Due to Aged Polyethylene Material
FDA (Devices) · 2026-09-23
- SevereHowmedica Recalls Scorpio Patella Implants Due to Polyethylene Wear Risk
FDA (Devices) · 2026-09-23
Similar recalls
- HighBoston Scientific Recalls S-ICD Devices Due to Battery Depletion
FDA (Devices) · 2019-09-25
- SevereBoston Scientific Recalls Emblem S-ICD Devices Due to Energy Delivery Risk
FDA (Devices) · 2017-08-23
- SevereBoston Scientific Recalls Emblem MRI S-ICD Devices Due to Energy Delivery Risk
FDA (Devices) · 2017-08-23
- HighBoston Scientific Recalls 28 Subcutaneous Implantable Cardioverter Defibrillators
FDA (Devices) · 2019-09-25
- HighBoston Scientific EMBLEM S-ICD Subcutaneous Defibrillators Software Defect Causes Battery Display Error
FDA (Devices) · 2022-11-09
- SevereBoston Scientific Recalls EMBLEM S-ICD Model A209 Due to Electrical Overstress
FDA (Devices) · 2021-02-17