Reported Oct 22, 2025 · Ongoing
PROPONENT DR SL (Model L201)
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?
- PROPONENT DR SL (Model L201)
- Lot codes and dates
- GTIN 00802526559044
- Serial Numbers
760356760366760367760404760409760412760441760443760500. GTIN 00802526576379
- Serial numbers767280. GTIN 00802526559051
- Serial numbers
767088799586. GTIN 00802526576379
- Serial Numbers
270 of 270 codes
100164100165100174100186100243100767100800723990724576724581724583724597724612724614724616724619724620724640724644724645724654724658724663724664724665724666724670724671724698724700724701724703724724724731724732724733724747724752724753724756724765724766724768724770724773724774724781724785724786724797724807724809724810724811724812724813724814724815724816724817
- Serial numbers
411 of 411 codes
715757715779715795715799715805715842715905715993716005716044716045716063716066716148716182716190716208716250716292716306716315716423716514716543716610716629716680716715716721716759716779716803717000717018717053717070717098717099717108717153717156717166717197717302717306717313717369717378717413717593717600717700717816717878717896717906717931717963717994717996
- Serial Numbers
1,733 of 1,733 codes
100140100181100221100282100287100290100401100407100410100707100750100763100766100770100772100781100782100783100785100786100788100793100803100804100808100818100827100838100839713123714640714796715611715802715831715847715854715886715907715912715934715949715953715981715986715991716002716007716011716016716028716054716081716093716097716106716107716108716147716162
- Amount recalled
- 2,426 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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