Recall archive / FDA device enforcement

Model Number U128, VALITUDE CRT-P EL MRI — FDA record Z-0102-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 20, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Model Number U128, VALITUDE 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).
Classification: Class I
Recalling firm: Boston Scientific Corporation
Quantity: 28,911 units
Agency-reported status: Ongoing
Source record identifier: Z-0102-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	GTIN 00802526559402, Serial numbers: 100187, 100217, 100222, 100236, 100251, 100253, 100260, 100262, 100274, 100275, 100277, 100289, 100317, 100328, 100330, 100350, 100359, 100361, 100363, 100364, 100369, 100372, 100373, 100376, 100379, 100381, 100386, 100391, 100392, 100394, 100397, 100399, 100400, 100401, 100402, 100404, 100410, 100411, 100414, 100417, 100420, 100433, 100435, 100437, 100444, 100445, 100447, 100449, 100450, 100452, 100453, 100456, 100458, 100459, 100463, 100466, 100471, 100473, 100474, 100475, 100476, 100481, 100482, 100483, 100484, 100485, 100486, 100491, 100497, 100500, 100501, 100502, 100503, 100506, 100507, 100511, 100513, 100514, 100519, 100520, 100522, 100523, 100527, 100533, 100535, 100536, 100537, 100539, 100541, 100544, 100545, 100547, 100550, 100551, 100553, 100556, 100557, 100560, 100562, 100563, 100564, 100565, 100569, 100570, 100571, 100572, 100573, 100574, 100575, 100577, 100580, 100581, 100583, 100586, 100589, 100590, 100592, 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Label field

Details supplied by the agency

Lot, code or applicability

GTIN 00802526559402, Serial numbers: 100187, 100217, 100222, 100236, 100251, 100253, 100260, 100262, 100274, 100275, 100277, 100289, 100317, 100328, 100330, 100350, 100359, 100361, 100363, 100364, 100369, 100372, 100373, 100376, 100379, 100381, 100386, 100391, 100392, 100394, 100397, 100399, 100400, 100401, 100402, 100404, 100410, 100411, 100414, 100417, 100420, 100433, 100435, 100437, 100444, 100445, 100447, 100449, 100450, 100452, 100453, 100456, 100458, 100459, 100463, 100466, 100471, 100473, 100474, 100475, 100476, 100481, 100482, 100483, 100484, 100485, 100486, 100491, 100497, 100500, 100501, 100502, 100503, 100506, 100507, 100511, 100513, 100514, 100519, 100520, 100522, 100523, 100527, 100533, 100535, 100536, 100537, 100539, 100541, 100544, 100545, 100547, 100550, 100551, 100553, 100556, 100557, 100560, 100562, 100563, 100564, 100565, 100569, 100570, 100571, 100572, 100573, 100574, 100575, 100577, 100580, 100581, 100583, 100586, 100589, 100590, 100592, 100593, 100595, 100596, 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...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

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Dates in the source

Report date: Oct 22, 2025
Recall initiation date: Aug 20, 2025
Center classification date: Oct 10, 2025

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