FDA Device recall Z-0105-2026

Model Number U228, VISIONIST CRT-P EL MRI

FDA Device
Class I
ongoing
Published 2025-10-22

On 2025-10-22 the FDA classified a Class I recall of Model Number U228, VISIONIST CRT-P EL MRI 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-0105-2026
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 U228, VISIONIST CRT-P EL MRI

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 00802526559471, Serial numbers: 726570, 728246, 728341, 728391, 728414, 728416, 728463, 728492, 728880, 732912, 7… GTIN 00802526559471, Serial numbers: 726570, 728246, 728341, 728391, 728414, 728416, 728463, 728492, 728880, 732912, 733290, 733427, 733464, 733475, 733541, 733672, 733700, 733703, 733748, 733749, 733755, 733756, 733773, 733776, 733778, 733791, 733792, 733794, 733797, 733799, 733800, 733801, 733804, 733805, 733807, 733808, 733811, 733812, 733815, 733818, 733819, 733820, 733824, 733829, 733830, 733832, 733833, 733834, 733841, 733842, 733843, 733846, 733851, 733852, 733853, 733854, 733859, 733861, 733862, 733864, 733876, 733880, 733881, 733883, 733887, 733888, 733895, 733896, 733897, 733898, 733899, 733904, 733907, 733908, 733909, 733916, 733925, 733926, 733927, 733928, 733931, 733934, 733935, 733936, 733939, 733944, 733960, 733976, 733980, 733982, 734809, 734811, 734812, 734822, 734824, 734837, 734844, 734870, 734880, 734884, 734899, 734902, 734939, 734944, 734955, 734960, 734967, 734977, 734982, 734991, 734992, 734997, 734998, 734999, 735005, 735006, 735013, 735015, 735024, 735028, 73

code_info

GTIN 00802526559471, Serial numbers: 726570, 728246, 728341, 728391, 728414, 728416, 728463, 728492, 728880, 732912, 7…

GTIN 00802526559471, Serial numbers: 726570, 728246, 728341, 728391, 728414, 728416, 728463, 728492, 728880, 732912, 733290, 733427, 733464, 733475, 733541, 733672, 733700, 733703, 733748, 733749, 733755, 733756, 733773, 733776, 733778, 733791, 733792, 733794, 733797, 733799, 733800, 733801, 733804, 733805, 733807, 733808, 733811, 733812, 733815, 733818, 733819, 733820, 733824, 733829, 733830, 733832, 733833, 733834, 733841, 733842, 733843, 733846, 733851, 733852, 733853, 733854, 733859, 733861, 733862, 733864, 733876, 733880, 733881, 733883, 733887, 733888, 733895, 733896, 733897, 733898, 733899, 733904, 733907, 733908, 733909, 733916, 733925, 733926, 733927, 733928, 733931, 733934, 733935, 733936, 733939, 733944, 733960, 733976, 733980, 733982, 734809, 734811, 734812, 734822, 734824, 734837, 734844, 734870, 734880, 734884, 734899, 734902, 734939, 734944, 734955, 734960, 734967, 734977, 734982, 734991, 734992, 734997, 734998, 734999, 735005, 735006, 735013, 735015, 735024, 735028, 73

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-0105-2026%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.