Reported Oct 22, 2025 · Ongoing
Model Number L231, PROPONENT DR EL MRI Pacemaker
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 L231, PROPONENT DR EL MRI Pacemaker
- Lot codes and dates
- GTIN 00802526559143
- Serial Numbers
756161799038841168. GTIN 00802526576423
- Serial Numbers
532638880141973836. GTIN 00802526578052
- Serial Numbers
594082727921812172832267899037944246978524. GTIN 00802526559143
- Serial Numbers
4,043 of 4,043 codes
100008100026100030100038100045100046100052100053100059100061100066100077100078100079100081100083100087100088100099100104100105100108100114100126100130100134100136100142100148100151100153100154100156100161100162100163100164100165100168100172100175100178100180100181100187100188100190100191100193100196100199100201100203100205100206100207100208100210100212100213
- Amount recalled
- 63,851 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.
Want the full recall guide?
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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