FDA Device recall Z-2015-2021

ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (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 ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (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-2015-2021
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

ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (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) J064, Serial Numbers: 390022, 390405, 100027, 100085, 100096, 100127, 100182, 100228, 100248, 100267, 100449, 10049… a) J064, Serial Numbers: 390022, 390405, 100027, 100085, 100096, 100127, 100182, 100228, 100248, 100267, 100449, 100491, 100495, 100543, 100575, 100634, 100651, 100659, 100704, 100707, 100741, 100789, 100806, 100907, 100961, 101002, 101003, 101061, 101160, 101166, 101183, 101208, 101253, 101255, 101344, 101415, 101416, 101421, 101438, 101445, 101448, 101450, 101452, 101459, 101693, 101721, 101850, 102002, 102003, 102017, 102018, 102020, 102030, 102144, 102180, 102295, 102297, 102333, 102348, 102350, 102353, 102366, 102368, 102369, 102381, 102425, 102440, 102458, 102474, 102482, 102590, 102594, 102596, 102600, 102602, 102603, 102604, 102612, 102615, 102616, 102617, 102618, 102752, 102753, 102801, 102819, 102842, 102894, 102896, 102924, 102962, 102966, 102973, 102976, 103000, 103002, 103004, 103013, 103014, 103015, 103021, 103027, 103042, 103043, 103046, 103075, 103081, 103084, 103089, 103095, 103117, 103121, 103128, 103147, 103157, 103160, 103169, 103177, 103187, 103194, 103199, 103203

code_info

a) J064, Serial Numbers: 390022, 390405, 100027, 100085, 100096, 100127, 100182, 100228, 100248, 100267, 100449, 10049…

a) J064, Serial Numbers: 390022, 390405, 100027, 100085, 100096, 100127, 100182, 100228, 100248, 100267, 100449, 100491, 100495, 100543, 100575, 100634, 100651, 100659, 100704, 100707, 100741, 100789, 100806, 100907, 100961, 101002, 101003, 101061, 101160, 101166, 101183, 101208, 101253, 101255, 101344, 101415, 101416, 101421, 101438, 101445, 101448, 101450, 101452, 101459, 101693, 101721, 101850, 102002, 102003, 102017, 102018, 102020, 102030, 102144, 102180, 102295, 102297, 102333, 102348, 102350, 102353, 102366, 102368, 102369, 102381, 102425, 102440, 102458, 102474, 102482, 102590, 102594, 102596, 102600, 102602, 102603, 102604, 102612, 102615, 102616, 102617, 102618, 102752, 102753, 102801, 102819, 102842, 102894, 102896, 102924, 102962, 102966, 102973, 102976, 103000, 103002, 103004, 103013, 103014, 103015, 103021, 103027, 103042, 103043, 103046, 103075, 103081, 103084, 103089, 103095, 103117, 103121, 103128, 103147, 103157, 103160, 103169, 103177, 103187, 103194, 103199, 103203

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-2015-2021%22

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