Reported Oct 22, 2025 · Ongoing
Model Number L221 PROPONENT DR EL 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 L221 PROPONENT DR EL Pacemaker
- Lot codes and dates
- GTIN 00802526578045
- Serial Numbers
723080723248725570729255. GTIN 00802526559129
- Serial Numbers732639. GTIN 00802526576416
- Serial numbers
222 of 222 codes
100156100157100167100180100185100247100254100263100268100272100278100279100282100293100296100302100304100305100306100308100314100315100332100335100336100453702524702763703141703183703341703490704875705065705069706965707072707119707355707474707499707999708019708170708229709024712293712330712402712408712424712437712517713937714362714643714710714836714847715761
- Serial Numbers
3,365 of 3,365 codes
100200100307100313100316100327100329702672702711702810702921703010703011703012703080703124703130703143703149703156703177703180703184703185703189703195703204703228703230703234703235703243703244703252703256703257703265703267703268703270703272703273703279703283703284703288703296703297703298703299703300703303703307703311703312703313703315703322703323703329703439
- Amount recalled
- 3592 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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