Reported May 6, 2026 · Ongoing
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled…
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?
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as
22 of 22 products
| Model / number | Product as published |
|---|---|
L100 | ESSENTIO SR SL |
L101 | ESSENTIO DR SL Pacemaker |
L110 | ESSENTIO SR SL MRI Pacemaker |
L111 | ESSENTIO DR SL MRI Pacemaker |
L121 | ESSENTIO DR EL Pacemaker |
L131 | ESSENTIO DR EL MRI Pacemaker |
L200 | PROPONENT SR SL Pacemaker |
L201 | PROPONENT DR SL Pacemaker |
L209 | PROPONENT DR (VDD) SL Pacemaker |
L210 | PROPONENT SR SL Pacemaker |
L211 | PROPONENT DR SL MRI Pacemaker |
L221 | PROPONENT DR EL Pacemaker |
L231 | PROPONENT DR EL MRI Pacemaker, * |
L300 | ACCOLADE SR SL Pacemaker |
L301 | ACCOLADE DR SL Pacemaker |
L310 | ACCOLADE SR SL MRI Pacemaker |
L311 | ACCOLADE DR SL MRI Pacemaker |
L321 | ACCOLADE DR EL Pacemaker |
L331 | ACCOLADE DR EL MRI Pacemaker, * |
S701 | ALTRUA 2 SR SL Pacemaker |
- Lot codes and dates
- The advisory population includes all models listed; however
- the bounding differs by battery type" All serialized DR-EL pacemakers and CRT-Ps from the ACCOLADE family are included in the advisory population. " ACCOLADE DR-SL and SR-SLs with a use-by-date (UBD) on or before 30 June 2025 are included in the advisory population. Model number alone will not precisely identify individual DR-SL or SR-SL devices in the advisory population. To determine if a device is affected, enter a model/serial into the device lookup tool at www.BostonScientific.com/lookup
- Amount recalled
- 718,456 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Stop using this product now
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia
Using this product could cause serious injury, illness or death — stop using it now.
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