Recall archive / FDA device enforcement

Model Number L121 ESSENTIO DR EL Pacemaker — FDA record Z-0096-2026

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 L121 ESSENTIO DR EL 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).
Classification: Class I
Recalling firm: Boston Scientific Corporation
Quantity: 10,833 units
Agency-reported status: Ongoing
Source record identifier: Z-0096-2026

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
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Label field

Details supplied by the agency

Lot, code or applicability

GTIN 00802526559242, Serial Numbers: 100009, 100026, 100029, 100030, 100031, 100042, 100189, 100192, 100207, 100290, 100309, 100310, 100311, 100312, 100317, 100320, 100322, 100324, 100328, 100331, 100333, 100334, 100362, 100368, 100375, 100377, 100382, 100383, 100385, 100386, 100394, 100397, 100399, 100400, 100402, 100404, 100406, 100407, 100408, 100410, 100411, 100412, 100413, 100414, 100415, 100417, 100420, 100423, 100424, 100425, 100428, 100429, 100430, 100431, 100433, 100435, 100438, 100440, 100444, 100445, 100448, 100449, 100450, 100454, 100456, 100457, 100458, 100459, 100461, 100462, 100463, 100464, 100466, 100470, 100474, 100480, 100491, 100492, 100495, 100497, 100498, 100500, 100501, 100503, 100506, 100510, 100513, 100515, 100521, 100522, 100525, 100527, 100530, 100534, 100535, 100537, 100538, 100541, 100542, 100554, 100555, 100556, 100558, 100559, 100560, 100561, 100562, 100563, 100567, 100570, 100571, 100582, 100590, 100594, 100596, 100599, 100604, 100605, 100606, 100607, 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...

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

Match all identifying details in the current notice. A brand name alone is not enough.

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Worldwide

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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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Lot and product identifiers

Distribution

Dates in the source

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