Boston Scientific Recalls Emblem MRI S-ICD Devices Due to Energy Delivery Risk
Boston Scientific is recalling approximately 9,200 Emblem MRI S-ICD devices because memory corruption may cause the device to deliver an atypical amount of energy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, and the hazard involves a medical device delivering atypical energy, which constitutes a significant injury risk per the rubric for Class II recalls with potential for significant harm.
Plain-English summary
Boston Scientific Corporation is recalling approximately 9,200 Emblem MRI S-ICD Model 219 Subcutaneous-Implantable Cardioverter Defibrillators. The recall affects all serial numbers of the device. 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 bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.
The recall was initiated because the device can deliver an atypical amount of energy due to memory corruption inside the device. This defect poses a risk to patients who rely on the device for defibrillation therapy.
The devices were distributed nationwide in the United States, including Puerto Rico, the U.S. Virgin Islands, and Guam, as well as worldwide, including Canada. 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 MRI S-ICD Model 219, 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…
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 9,200
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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