FDA Device recall Z-2016-2021

INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

FDA Device
Class I
ongoing
Published 2021-07-21

On 2021-07-21 the FDA classified a Class I recall of INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021) by Boston Scientific, citing the dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Expl….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2016-2021
Classification	Class I
Status	ongoing
Initiated	2021-06-03
Published	2021-07-21
Last updated	2026-09-13 11:56 UTC
Company	Boston Scientific
Distribution	n/a

Product

INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

Reason

The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population

Identifiers

code_info	a) J174, Serial Numbers: 100017, 100107, 100122, 100124, 100174, 100278, 100284, 100374, 100377, 100430, 100596, 10063… a) J174, Serial Numbers: 100017, 100107, 100122, 100124, 100174, 100278, 100284, 100374, 100377, 100430, 100596, 100636, 100685, 100725, 101002, 101103, 101241, 101331, 101348, 101410, 101413, 101442, 101627, 101648, 101682, 101753, 101964, 101981, 101982, 102019, 102043, 102156, 102160, 102261, 102262, 102331, 102333, 102370, 102376, 102476, 102482, 102717, 102813, 102826, 102838, 102908, 103055, 103071, 103086, 103127, 103146, 103198, 103209, 103212, 103218, 103245, 103248, 103291, 103296, 103330, 103414, 103489, 103529, 103600, 103710, 103753, 103812, 103842, 103865, 103985, 104045, 104059, 104075, 104079, 104120, 104138, 104205, 104211, 104291, 104318, 104346, 104353, 104386, 104391, 104399, 104483, 104558, 104690, 104803, 104877, 104881, 104883, 104898, 104901, 104922, 104933, 104958, 104982, 105010, 105023, 105086, 105144, 105147, 105157, 105163, 105169, 105170, 105178, 105225, 105237, 105240, 105314, 105335, 105360, 105389, 105400, 105402, 105430, 105441, 105444, 105446, 105469

code_info

a) J174, Serial Numbers: 100017, 100107, 100122, 100124, 100174, 100278, 100284, 100374, 100377, 100430, 100596, 10063…

a) J174, Serial Numbers: 100017, 100107, 100122, 100124, 100174, 100278, 100284, 100374, 100377, 100430, 100596, 100636, 100685, 100725, 101002, 101103, 101241, 101331, 101348, 101410, 101413, 101442, 101627, 101648, 101682, 101753, 101964, 101981, 101982, 102019, 102043, 102156, 102160, 102261, 102262, 102331, 102333, 102370, 102376, 102476, 102482, 102717, 102813, 102826, 102838, 102908, 103055, 103071, 103086, 103127, 103146, 103198, 103209, 103212, 103218, 103245, 103248, 103291, 103296, 103330, 103414, 103489, 103529, 103600, 103710, 103753, 103812, 103842, 103865, 103985, 104045, 104059, 104075, 104079, 104120, 104138, 104205, 104211, 104291, 104318, 104346, 104353, 104386, 104391, 104399, 104483, 104558, 104690, 104803, 104877, 104881, 104883, 104898, 104901, 104922, 104933, 104958, 104982, 105010, 105023, 105086, 105144, 105147, 105157, 105163, 105169, 105170, 105178, 105225, 105237, 105240, 105314, 105335, 105360, 105389, 105400, 105402, 105430, 105441, 105444, 105446, 105469

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-2016-2021%22

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