FDA Device recall Z-0101-2026

Model Number U125, VALITUDE 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 U125, VALITUDE 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-0101-2026
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 U125, VALITUDE 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 00802526559389, Serial numbers: 100095, 100182, 100194, 100221, 100236, 100239, 100242, 100243, 100247, 100254, 1… GTIN 00802526559389, Serial numbers: 100095, 100182, 100194, 100221, 100236, 100239, 100242, 100243, 100247, 100254, 100258, 100259, 100263, 100270, 100285, 100287, 100292, 100298, 100301, 100302, 100307, 100310, 100315, 100323, 100331, 100333, 100339, 100342, 100343, 100348, 100349, 100350, 100357, 100358, 100359, 100360, 100362, 100366, 100367, 100371, 100372, 100375, 100378, 100386, 100390, 100392, 100394, 100396, 100397, 100401, 100402, 100403, 100406, 100409, 100412, 100413, 100418, 100419, 100420, 100423, 100429, 100430, 100432, 100435, 100438, 100448, 100452, 100453, 100455, 100456, 100458, 100462, 100466, 100467, 100472, 100473, 100475, 100476, 100480, 100481, 100482, 100485, 100486, 100489, 100492, 100493, 100495, 100496, 100497, 100498, 100499, 100500, 100502, 100505, 100510, 100514, 100518, 100526, 100529, 100532, 100533, 100536, 100537, 100539, 100540, 100541, 100544, 100546, 100548, 100549, 100552, 100560, 100566, 100570, 100572, 100573, 100575, 100576, 100578, 100582, 10

code_info

GTIN 00802526559389, Serial numbers: 100095, 100182, 100194, 100221, 100236, 100239, 100242, 100243, 100247, 100254, 1…

GTIN 00802526559389, Serial numbers: 100095, 100182, 100194, 100221, 100236, 100239, 100242, 100243, 100247, 100254, 100258, 100259, 100263, 100270, 100285, 100287, 100292, 100298, 100301, 100302, 100307, 100310, 100315, 100323, 100331, 100333, 100339, 100342, 100343, 100348, 100349, 100350, 100357, 100358, 100359, 100360, 100362, 100366, 100367, 100371, 100372, 100375, 100378, 100386, 100390, 100392, 100394, 100396, 100397, 100401, 100402, 100403, 100406, 100409, 100412, 100413, 100418, 100419, 100420, 100423, 100429, 100430, 100432, 100435, 100438, 100448, 100452, 100453, 100455, 100456, 100458, 100462, 100466, 100467, 100472, 100473, 100475, 100476, 100480, 100481, 100482, 100485, 100486, 100489, 100492, 100493, 100495, 100496, 100497, 100498, 100499, 100500, 100502, 100505, 100510, 100514, 100518, 100526, 100529, 100532, 100533, 100536, 100537, 100539, 100540, 100541, 100544, 100546, 100548, 100549, 100552, 100560, 100566, 100570, 100572, 100573, 100575, 100576, 100578, 100582, 10

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-0101-2026%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.