--- title: "Model Number U225 VISIONIST CRT-P EL — FDA record Z-0103-2026 | Is It on Recall" description: "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" url: https://isitonrecall.com/recall/fda-device-z-0103-2026-model-number-u225-visionist-crt-p-el/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Model Number U225 VISIONIST CRT-P EL — FDA record Z-0103-2026 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Model Number U225 VISIONIST 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). - **Classification**: Class I - **Recalling firm**: Boston Scientific Corporation - **Quantity**: 12,326 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0103-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0103-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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 00802526559426, Serial numbers: 709683, 709711, 709737, 709778, 709780, 709789, 709792, 709794, 709804, 709815, 709816, 709827, 709828, 709829, 709830, 709831, 709889, 709907, 709912, 709914, 709926, 709935, 709938, 709941, 709943, 709962, 709965, 709966, 709969, 709985, 710005, 710016, 710027, 710105, 710235, 710283, 710379, 710386, 710408, 710414, 710416, 710418, 710424, 710438, 710443, 710450, 710458, 710459, 710466, 710467, 710479, 710481, 710482, 710490, 710540, 710544, 710545, 710558, 710561, 710566, 710571, 710572, 710575, 710586, 710593, 710595, 710600, 710613, 710622, 710624, 711100, 711103, 711115, 711116, 711186, 711234, 711261, 711493, 711497, 711646, 711698, 711699, 711704, 711706, 711719, 711756, 711771, 711780, 711781, 711783, 711784, 711812, 711817, 711852, 711859, 711865, 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[Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0103-2026%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide No US distribution state could be established from this record. Check the official notice. ## Dates in the source - **Report date**: Oct 22, 2025 - **Recall initiation date**: Aug 20, 2025 - **Center classification date**: Oct 10, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0103-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Boston Scientific Corporation records](https://isitonrecall.com/brand/boston-scientific-corporation/)