Z-3259-2018Class II

VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)

Name: Z-3259-2018 VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Creator: Boston Scientific Corporation
Published: 2018-09-10
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2018-09-10 / Terminated / root cause: design

FDA source

Boston Scientific Corporation began a recall of VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker) on 2018-09-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3259-2018
Classification: Class II
Status: Terminated
Initiated: 2018-09-10
Posted: 2018-09-27
Terminated: 2019-11-04
Recalling firm: Boston Scientific Corporation
Product: VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
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.
Root cause tag: design
FDA root 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
Product codes and lots: VISIONIST X4 (CRT-P) model U228

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3259-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3255-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27
Z-3256-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27
Z-3257-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27
Z-3258-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27
Z-3259-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)