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U.S. Department of Health and Human Services

Class 2 Device Recall Accolade MRI and Essentio MRI pacemakers

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  Class 2 Device Recall Accolade MRI and Essentio MRI pacemakers see related information
Date Initiated by Firm June 15, 2016
Date Posted September 07, 2016
Recall Status1 Terminated 3 on February 06, 2017
Recall Number Z-2749-2016
Recall Event ID 74812
PMA Number P150012 
Product Classification Implantable pulse generator, pacemaker (non-CRT) - Product Code LWP
Product 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.

Code Information serial numbers 215173, 215186, 215507, 215855, 215957, 216051, 218956, 710312, and 710541.
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact
651-582-4000
Manufacturer 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.
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 5
Distribution Distributed to the states of TX, NH, MA, PA, and MN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LWP and Original Applicant = BOSTONSCIENTIFIC
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