FDA Device recall Z-2017-2021

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f)…

FDA Device
Class I
ongoing
Published 2021-07-21

On 2021-07-21 the FDA classified a Class I recall of VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f)… 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-2017-2021
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

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (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) J274, Serial Numbers: 100000, 100001, 100005, 100008, 100009, 100010, 100016, 100017, 100019, 100021, 100026, 10002… a) J274, Serial Numbers: 100000, 100001, 100005, 100008, 100009, 100010, 100016, 100017, 100019, 100021, 100026, 100028, 100031, 100032, 100033, 100034, 100036, 100037, 100038, 100041, 100042, 100044, 100045, 100046, 100047, 100049, 100051, 100052, 100055, 100056, 100057, 100060, 100062, 100075, 100084, 100088, 100095, 100098, 100100, 100101, 100102, 100103, 100106, 100107, 100109, 100112, 100114, 100115, 100116, 100118, 100120, 100121, 395016, 100012, 100013, 100018, 100020, 100029, 100030, 100043, 100054, 100065, 100105, 100117, 394733, 394736, 394741, 394742, 394743, 394745, 394746, 394747, 394748, 394749, 394750, 394751, 394752, 394753, 394754, 394755, 394756, 394757, 394758, 394759, 394762, 394763, 394764, 394765, 394766, 394767, 394768, 394769, 394770, 394771, 394772, 394773, 394774, 394775, 394776, 394777, 394778, 394779, 394780, 394781, 394782, 394783, 394784, 394785, 394786, 394787, 394788, 394789, 394790, 394791, 394792, 394793, 394794, 394795, 394796, 394797, 394798, 394799

code_info

a) J274, Serial Numbers: 100000, 100001, 100005, 100008, 100009, 100010, 100016, 100017, 100019, 100021, 100026, 10002…

a) J274, Serial Numbers: 100000, 100001, 100005, 100008, 100009, 100010, 100016, 100017, 100019, 100021, 100026, 100028, 100031, 100032, 100033, 100034, 100036, 100037, 100038, 100041, 100042, 100044, 100045, 100046, 100047, 100049, 100051, 100052, 100055, 100056, 100057, 100060, 100062, 100075, 100084, 100088, 100095, 100098, 100100, 100101, 100102, 100103, 100106, 100107, 100109, 100112, 100114, 100115, 100116, 100118, 100120, 100121, 395016, 100012, 100013, 100018, 100020, 100029, 100030, 100043, 100054, 100065, 100105, 100117, 394733, 394736, 394741, 394742, 394743, 394745, 394746, 394747, 394748, 394749, 394750, 394751, 394752, 394753, 394754, 394755, 394756, 394757, 394758, 394759, 394762, 394763, 394764, 394765, 394766, 394767, 394768, 394769, 394770, 394771, 394772, 394773, 394774, 394775, 394776, 394777, 394778, 394779, 394780, 394781, 394782, 394783, 394784, 394785, 394786, 394787, 394788, 394789, 394790, 394791, 394792, 394793, 394794, 394795, 394796, 394797, 394798, 394799

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-2017-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.