FDA Device recall Z-0103-2026

Model Number U225 VISIONIST CRT-P EL

FDA Device
Class I
ongoing
Published 2025-10-22

On 2025-10-22 the FDA classified a Class I recall of Model Number U225 VISIONIST CRT-P EL 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-0103-2026
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 U225 VISIONIST CRT-P EL

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 00802526559426, Serial numbers: 709683, 709711, 709737, 709778, 709780, 709789, 709792, 709794, 709804, 709815, 7… GTIN 00802526559426, Serial numbers: 709683, 709711, 709737, 709778, 709780, 709789, 709792, 709794, 709804, 709815, 709816, 709827, 709828, 709829, 709830, 709831, 709889, 709907, 709912, 709914, 709926, 709935, 709938, 709941, 709943, 709962, 709965, 709966, 709969, 709985, 710005, 710016, 710027, 710105, 710235, 710283, 710379, 710386, 710408, 710414, 710416, 710418, 710424, 710438, 710443, 710450, 710458, 710459, 710466, 710467, 710479, 710481, 710482, 710490, 710540, 710544, 710545, 710558, 710561, 710566, 710571, 710572, 710575, 710586, 710593, 710595, 710600, 710613, 710622, 710624, 711100, 711103, 711115, 711116, 711186, 711234, 711261, 711493, 711497, 711646, 711698, 711699, 711704, 711706, 711719, 711756, 711771, 711780, 711781, 711783, 711784, 711812, 711817, 711852, 711859, 711865, 711867, 711870, 711881, 711894, 711896, 711901, 711913, 711915, 711916, 711927, 711929, 711933, 711941, 711977, 711984, 712029, 712100, 712114, 712120, 712122, 712140, 712143, 712187, 712188, 71

code_info

GTIN 00802526559426, Serial numbers: 709683, 709711, 709737, 709778, 709780, 709789, 709792, 709794, 709804, 709815, 7…

GTIN 00802526559426, Serial numbers: 709683, 709711, 709737, 709778, 709780, 709789, 709792, 709794, 709804, 709815, 709816, 709827, 709828, 709829, 709830, 709831, 709889, 709907, 709912, 709914, 709926, 709935, 709938, 709941, 709943, 709962, 709965, 709966, 709969, 709985, 710005, 710016, 710027, 710105, 710235, 710283, 710379, 710386, 710408, 710414, 710416, 710418, 710424, 710438, 710443, 710450, 710458, 710459, 710466, 710467, 710479, 710481, 710482, 710490, 710540, 710544, 710545, 710558, 710561, 710566, 710571, 710572, 710575, 710586, 710593, 710595, 710600, 710613, 710622, 710624, 711100, 711103, 711115, 711116, 711186, 711234, 711261, 711493, 711497, 711646, 711698, 711699, 711704, 711706, 711719, 711756, 711771, 711780, 711781, 711783, 711784, 711812, 711817, 711852, 711859, 711865, 711867, 711870, 711881, 711894, 711896, 711901, 711913, 711915, 711916, 711927, 711929, 711933, 711941, 711977, 711984, 712029, 712100, 712114, 712120, 712122, 712140, 712143, 712187, 712188, 71

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-0103-2026%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.