Class 2 Device Recall VISIONIST X4 CRTP (Cardiac Resynchronization Therapy Pacemaker)

• Date Initiated by Firm: September 10, 2018
• Create Date: September 27, 2018
• Recall Status: Terminated on November 04, 2019
• Recall Number: Z-3259-2018
• Recall Event ID: 81001
• PMA Number: P030005
• Product Classification: Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
• Product: VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
• Code Information: VISIONIST X4 (CRT-P) model U228
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 4100 Hamline Ave N Bldg 3; Saint Paul MN 55112-5700
• For Additional Information Contact: United States Technical Services; 800-227-3422
• Manufacturer Reason for Recall: Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
• FDA Determined Cause: Component design/selection
• Action: On September 2018 Boston Scientific sent letters to their customers with the following information: Dear Doctor, Boston Scientific has identified a subset of approximately 2,900 active ACCOLADE", PROPONENT", and ESSENTIO" pacemakers and VISIONIST" and VALITUDE" cardiac resynchronization therapy pacemakers (CRT-Ps) with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion. There have been no reports of injury related to this behavior. You are receiving this letter because you or your center has implanted or follow one or more patients with a pacemaker in this subset. This device behavior can be identified via the regular pacemaker follow-up process, either in-clinic or through the LATITUDE" NXT Remote Patient Management System (LATITUDE). Therefore, a follow-up interval of no more than six (6) months is recommended and is consistent with existing international societal guidelines1. If accelerated depletion is suspected, Boston Scientific recommends consultation with Technical Services to review the pacemaker diagnostic data available from either a recent data upload in LATITUDE or a Save to Disk to confirm accelerated depletion and determine an appropriate timeframe for pacemaker replacement. Description The pacemaker manual describes how increases in pacing requirements or changes in programmed parameters may result in an expected longevity reduction and are considered normal battery depletion. However, hydrogen exposure within the pacemakers circuitry may compromise the electrical performance of low voltage capacitors causing current leakage and a moderate acceleration in the rate of battery depletion. Because this accelerated depletion does not occur rapidly, a follow-up interval of no more than six months is recommended. Boston Scientific has determined a liner component to be the source of hydrogen and identified a subset of previously distributed pacemakers that have an elevated potential for exh
• Distribution: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, W A, WI, WV, and WY
• 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.