Boston Scientific Corporation recalls Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse gene…

Recall date

June 15, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2749-2016

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

Distributed to the states of TX, NH, MA, PA, and MN.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.