Boston Scientific Corporation: ESSENTIO Pacemaker

Recall number

Z-3255-2018

Recalling firm

Boston Scientific Corporation

Product

ESSENTIO Pacemaker

Status

Terminated

Initiated

2018-09-10

Posted

not on file

Terminated

2019-11-04

Reason

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

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

Quantity

not on file

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

Lot, serial or model codes

ESSENTIO SR model L100, ESSENTIO DR model L101, ESSENTIO MRI SR model L110, ESSENTIO MRI DR model L111, ESSENTIO EL DR model L121, and ESSENTIO MRI EL DR model L131

510(k) numbers

not on file

PMA numbers

["P150012"]

Product code

LWS

Firm FEI

2124215

Firm city

Saint Paul

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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