Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Pacemakers: Accolade MRI DR Model L311 Recalled by Boston Scientific Corporation Due to Five Accolate MRI and Essentio MRI DR pulse...
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
Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.
Quantity: 5
Why Was This Recalled?
Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shipped to US customers and implanted. This alternate configuration did not receive FDA approval yet.
Where Was This Sold?
This product was distributed to 5 states: MA, MN, NH, PA, TX
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