FDA Device recall Z-1998-2021

Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131

FDA Device
Class II
ongoing
Published 2021-07-14

On 2021-07-14 the FDA classified a Class II recall of Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131 by Boston Scientific, citing latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery de….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1998-2021
Classification	Class II
Status	ongoing
Initiated	2021-06-03
Published	2021-07-14
Last updated	2026-09-13 11:56 UTC
Company	Boston Scientific
Distribution	n/a

Product

Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131

Reason

Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.

Identifiers

code_info	a) L100, Serial Numbers: 464190, 464192, 464197, 464199, 464209, 464211, 464228, 464229, 464230, 464238, 464253, 46425… a) L100, Serial Numbers: 464190, 464192, 464197, 464199, 464209, 464211, 464228, 464229, 464230, 464238, 464253, 464258, 464259, 464279, 464295, 464296, 464297, 464308, 464312, 464316, 464321, 464322, 464325, 464348, 464358, 464360, 464361, 464362, 464363, 464364, 464369, 464371, 464373, 464378, 464379, 464380, 464383, 464384, 464392, 464393, 464394, 464398, 464400, 464406, 464408, 464409, 464410, 464411, 464412, 464414, 464415, 464421, 464425, 464427, 464428, 464430, 464431, 464432, 464435, 464437, 464440, 464441, 464442, 464443, 464445, 464451, 464455, 464456, 464465, 464466, 464469, 464474, 464480, 464484, 464485, 464487, 464488, 464489, 464493, 464496, 464502, 464503, 464504, 464507, 464520, 464529, 464531, 464534, 464538, 464544, 464546, 464547, 464551, 464556, 464558, 464560, 464566, 464567, 464571, 464573, 464577, 464578, 464583, 464585, 464586, 464587, 464588, 464591, 464592, 464598, 464599, 464604, 464608, 464609, 464611, 464616, 464617, 464623, 464625, 464629, 464635, 464637

code_info

a) L100, Serial Numbers: 464190, 464192, 464197, 464199, 464209, 464211, 464228, 464229, 464230, 464238, 464253, 46425…

a) L100, Serial Numbers: 464190, 464192, 464197, 464199, 464209, 464211, 464228, 464229, 464230, 464238, 464253, 464258, 464259, 464279, 464295, 464296, 464297, 464308, 464312, 464316, 464321, 464322, 464325, 464348, 464358, 464360, 464361, 464362, 464363, 464364, 464369, 464371, 464373, 464378, 464379, 464380, 464383, 464384, 464392, 464393, 464394, 464398, 464400, 464406, 464408, 464409, 464410, 464411, 464412, 464414, 464415, 464421, 464425, 464427, 464428, 464430, 464431, 464432, 464435, 464437, 464440, 464441, 464442, 464443, 464445, 464451, 464455, 464456, 464465, 464466, 464469, 464474, 464480, 464484, 464485, 464487, 464488, 464489, 464493, 464496, 464502, 464503, 464504, 464507, 464520, 464529, 464531, 464534, 464538, 464544, 464546, 464547, 464551, 464556, 464558, 464560, 464566, 464567, 464571, 464573, 464577, 464578, 464583, 464585, 464586, 464587, 464588, 464591, 464592, 464598, 464599, 464604, 464608, 464609, 464611, 464616, 464617, 464623, 464625, 464629, 464635, 464637

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1998-2021%22

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