FDA Device recall Z-0095-2026

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Device
Class I
ongoing
Published 2025-10-22

On 2025-10-22 the FDA classified a Class I recall of Model Number L111, ESSENTIO DR SL MRI Pacemaker by Boston Scientific, citing software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOL….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0095-2026
Classification	Class I
Status	ongoing
Initiated	2025-08-20
Published	2025-10-22
Last updated	2026-09-13 11:57 UTC
Company	Boston Scientific
Distribution	n/a

Product

Model Number L111, ESSENTIO DR SL MRI Pacemaker

Reason

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Identifiers

code_info	GTIN 00802526559228, Serial numbers: 103410, 200337, 200359, 200704, 201273, 201585, 202131, 203086, 204240, 204255, 2… GTIN 00802526559228, Serial numbers: 103410, 200337, 200359, 200704, 201273, 201585, 202131, 203086, 204240, 204255, 204383, 204472, 204532, 204553, 204558, 204581, 204619, 204644, 204658, 204672, 204680, 204704, 204729, 204735, 204748, 204768, 204779, 204855, 204883, 204891, 204907, 204916, 204929, 204934, 204947, 204951, 204957, 204959, 204968, 204985, 205002, 205044, 205073, 205083, 205105, 205130, 205149, 205192, 205199, 205211, 205227, 205233, 205236, 205290, 205360, 205362, 205363, 205408, 205412, 205413, 205415, 205455, 205480, 205543, 205553, 205560, 205585, 205586, 205587, 205625, 205632, 205636, 205672, 205673, 205686, 205688, 205733, 205742, 205767, 205770, 205773, 205782, 205791, 205796, 205797, 205810, 205854, 205855, 205857, 205861, 205863, 205907, 205911, 205920, 205940, 205945, 205946, 205958, 205961, 205965, 205967, 205971, 205975, 205977, 205979, 205989, 205992, 205997, 205998, 206011, 206019, 206033, 206045, 206046, 206049, 206069, 206070, 206074, 206075, 206080, 20

code_info

GTIN 00802526559228, Serial numbers: 103410, 200337, 200359, 200704, 201273, 201585, 202131, 203086, 204240, 204255, 2…

GTIN 00802526559228, Serial numbers: 103410, 200337, 200359, 200704, 201273, 201585, 202131, 203086, 204240, 204255, 204383, 204472, 204532, 204553, 204558, 204581, 204619, 204644, 204658, 204672, 204680, 204704, 204729, 204735, 204748, 204768, 204779, 204855, 204883, 204891, 204907, 204916, 204929, 204934, 204947, 204951, 204957, 204959, 204968, 204985, 205002, 205044, 205073, 205083, 205105, 205130, 205149, 205192, 205199, 205211, 205227, 205233, 205236, 205290, 205360, 205362, 205363, 205408, 205412, 205413, 205415, 205455, 205480, 205543, 205553, 205560, 205585, 205586, 205587, 205625, 205632, 205636, 205672, 205673, 205686, 205688, 205733, 205742, 205767, 205770, 205773, 205782, 205791, 205796, 205797, 205810, 205854, 205855, 205857, 205861, 205863, 205907, 205911, 205920, 205940, 205945, 205946, 205958, 205961, 205965, 205967, 205971, 205975, 205977, 205979, 205989, 205992, 205997, 205998, 206011, 206019, 206033, 206045, 206046, 206049, 206069, 206070, 206074, 206075, 206080, 20

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0095-2026%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.