Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EMBLEM MRI S-ICD Model 219 Recalled by Boston Scientific Corporation Due to The device can deliver an atypical amount of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.
Affected Products
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 bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing
Quantity: Approximately 9,200 devices
Why Was This Recalled?
The device can deliver an atypical amount of energy due to memory corruption inside the device.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report