Reported Oct 22, 2025 · Ongoing
Model Number U225 VISIONIST CRT-P EL
Boston Scientific Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 4100 Hamline Ave N · Saint Paul, MN · 55112-5700
Is this the product you have?
- Model Number U225 VISIONIST CRT-P EL
- Lot codes and dates
- GTIN 00802526559426
- Serial numbers
2,073 of 2,073 codes
709683709711709737709778709780709789709792709794709804709815709816709827709828709829709830709831709889709907709912709914709926709935709938709941709943709962709965709966709969709985710005710016710027710105710235710283710379710386710408710414710416710418710424710438710443710450710458710459710466710467710479710481710482710490710540710544710545710558710561710566
- Serial numbers
1,993 of 1,993 codes
100016100021100023100048100053100060100061100064100065100070100072100073100075100077100082100087100088100089100090100093100094100097100098100100100101100103100105100107100108100109100113100114100115100116100117100118100120100121100122100123100125100126100128100129100130100131100134100135100137100138100140100142100144100145100147100151100152100153100154100155
- Amount recalled
- 12,326 units
This recall covers 34 products
The agency filed one notice per product. You are reading one of them; the other 33 are below.
21 more are in the archive.
Why it was recalled
Stop using this product now
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).
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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