Model Number L101 — Class I medical device recall Z-0093-2026
Ongoing recall by Boston Scientific Corporation, reported 2025-10-22. Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an a
| Recall number | Z-0093-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2025-08-20 |
| Classified | 2025-10-10 |
| Reported by FDA | 2025-10-22 |
| Quantity | 22,714 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00802526559174, 00802526559181, 00802526576447, 00802526576942 |
| Serial numbers | 100547, 100752, 100822, 100843, 100852, 100853, 100857, 100863, 100865, 100866, 100868, 100871, 100874, 100879, 100883, 100884, 100889, 100891, 100892, 100893, 100897, 100900, 100914, 100915, 100916 and 475 more |
| Model numbers | L101 |
Product
Model Number L101, ESSENTIO DR SL Pacemaker
Reason for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0093-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.