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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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.
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