Recall archive / FDA device enforcement

Model Number U228, VISIONIST CRT-P EL MRI — FDA record Z-0105-2026

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 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).
Classification: Class I
Recalling firm: Boston Scientific Corporation
Quantity: 41,191 units
Agency-reported status: Ongoing
Source record identifier: Z-0105-2026

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

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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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Distribution

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