FDA Device recall Z-2000-2021

Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

FDA Device
Class II
ongoing
Published 2021-07-14

On 2021-07-14 the FDA classified a Class II recall of Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331 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-2000-2021
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

Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

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) L300, Serial Numbers: 712118, 713277, 713352, 713357, 713365, 713381, 713390, 713398, 713403, 713405, 713406, 71342… a) L300, Serial Numbers: 712118, 713277, 713352, 713357, 713365, 713381, 713390, 713398, 713403, 713405, 713406, 713420, 713440, 713443, 713447, 713454, 713456, 713459, 713461, 713464, 713469, 713470, 713474, 713480, 713483, 713500, 713501, 713506, 713508, 713513, 713515, 713516, 713519, 713528, 713530, 713538, 713542, 713543, 713544, 713548, 713592, 713593, 713614, 713621, 713624, 713625, 713630, 713631, 713633, 713637, 713642, 713646, 713649, 713650, 713651, 713652, 713666, 713669, 713675, 713682, 713695, 713701, 713711, 713719, 713728, 713732, 713738, 713744, 713755, 713766, 713796, 713799, 713842, 714095, 714101, 714274, 714280, 719937, 719963, 719998, 720049, 720218, 720222, 720253, 720280, 707669, 713278, 713312, 713318, 713319, 713320, 713326, 713333, 713335, 713363, 713368, 713372, 713385, 713386, 713388, 713389, 713393, 713399, 713401, 713404, 713407, 713408, 713409, 713411, 713414, 713419, 713426, 713431, 713445, 713446, 713449, 713450, 713453, 713457, 713458, 713460, 713462

code_info

a) L300, Serial Numbers: 712118, 713277, 713352, 713357, 713365, 713381, 713390, 713398, 713403, 713405, 713406, 71342…

a) L300, Serial Numbers: 712118, 713277, 713352, 713357, 713365, 713381, 713390, 713398, 713403, 713405, 713406, 713420, 713440, 713443, 713447, 713454, 713456, 713459, 713461, 713464, 713469, 713470, 713474, 713480, 713483, 713500, 713501, 713506, 713508, 713513, 713515, 713516, 713519, 713528, 713530, 713538, 713542, 713543, 713544, 713548, 713592, 713593, 713614, 713621, 713624, 713625, 713630, 713631, 713633, 713637, 713642, 713646, 713649, 713650, 713651, 713652, 713666, 713669, 713675, 713682, 713695, 713701, 713711, 713719, 713728, 713732, 713738, 713744, 713755, 713766, 713796, 713799, 713842, 714095, 714101, 714274, 714280, 719937, 719963, 719998, 720049, 720218, 720222, 720253, 720280, 707669, 713278, 713312, 713318, 713319, 713320, 713326, 713333, 713335, 713363, 713368, 713372, 713385, 713386, 713388, 713389, 713393, 713399, 713401, 713404, 713407, 713408, 713409, 713411, 713414, 713419, 713426, 713431, 713445, 713446, 713449, 713450, 713453, 713457, 713458, 713460, 713462

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-2000-2021%22

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