Model Number L221 PROPONENT DR EL Pacemaker
Pending LLM rewrite. Source: FDA_DEVICE Z-0090-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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).
The recalled product
- Product
- Model Number L221 PROPONENT DR EL Pacemaker
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00802526578045
- Serial Numbers: 723080
- 723248
- 725570
- 729255. GTIN 00802526559129. Serial Numbers: 732639. GTIN 00802526576416
- Serial numbers: 100156
- 100157
- 100167
- 100180
- 100185
- 100247
- 100254
- 100263
- 100268
- 100272
- 100278
- 100279
- 100282
- 100293
- 100296
Distribution
Distribution scope not specified by the agency.
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