Reported Oct 22, 2025 · Ongoing
PROPONENT SR SL (Model L200)
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 SR SL (Model L200)
- Lot codes and dates
- GTIN 00802526559020
- Serial numbers
722605722614722634722647. GTIN 00802526576362
- Serial numbers
214 of 214 codes
464359464382464387464444464447464457464462464471464505464511464514464517464521464525464527464541464549464552464554464561464576708351708451708466708471708495708513708514708515708516708517708525708529708532708533708536708618708619708620708622708623708624708625708627708630708651708653708654708655708656708658708660708737708751708764708783708816708824708826708857
- Serial Numbers
1,162 of 1,162 codes
464370464388464446464452464458464460464467464468464470464475464477464481464482464483464486464490464491464492464498464500464501464506464508464512464516464519464523464526464528464532464563464568464570464590705011705236705383705409705419705462705468705555705576705584705622705628705702705706705711705713705728705751705753705795705812706007706098706215706321706350
- Amount recalled
- 1380 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.
Free recall alerts
Get alerted about new Boston Scientific Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.