Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EMBLEM MRI S-ICD Pulse Generator Model A219 Recalled by Boston Scientific Corporation Due to There is a potential for a rare interaction...
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 Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator
Quantity: 41,411 units
Why Was This Recalled?
There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
Where Was This Sold?
Worldwide
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