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.
FDA Recall Z-2749-2016 · Posted 2016-09-07
Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLWP
Date Initiated2016-06-15
Date Terminated2017-02-06
Product Quantity5
Reason for Recall
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.
Firm Action
As we considered the value of a direct physician communication we have not identified any information that would be of value to the physician because device performance and behavior remain unchanged.
Root Cause
Process control
Distribution Pattern
Distributed to the states of TX, NH, MA, PA, and MN.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.