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PROPONENT™ SR L200Recalls & reported problems

Boston Scientific Corporation · Pacemaker · Class 3 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Aug 20, 2025Open, Classified

    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).

    Z-0085-2026 · Root cause: Other · FDA record ↗

Other Implantable pulse generator, pacemaker (non-CRT) devices

All Implantable pulse generator, pacemaker (non-CRT) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.