Boston Scientific Recalls Emblem S-ICD Devices Due to Energy Delivery Risk
Boston Scientific is recalling approximately 16,750 Emblem S-ICD devices because they may deliver atypical energy levels due to internal memory corruption.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, an FDA Class II recall involving a significant injury risk (atypical energy delivery in a life-saving cardiac device) corresponds to a severity score of 4 (Severe).
Plain-English summary
Boston Scientific Corporation is recalling approximately 16,750 Emblem S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillators. These prescription devices are intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.
The recall is being conducted because the devices can deliver an atypical amount of energy due to memory corruption inside the device. This defect poses a risk of inappropriate therapy delivery to patients.
The affected devices were distributed nationwide in the United States, including Puerto Rico, the U.S. Virgin Islands, and Guam, as well as in foreign countries including Canada. All serial numbers are included in this recall. Patients with these devices should contact their healthcare provider or Boston Scientific for further instructions regarding the recall and potential replacement or repair options.
The recalled product
- Product
- EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradyc
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiac Implant
- Affected units
- 16,750
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Part of a larger recall action
This product is one of 3 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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