Model Number U128 — Class I medical device recall Z-0102-2026
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-0102-2026 |
|---|---|
| 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 | 28,911 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00802526559402, 00802526559419, 00802526576522, 00802526578120 |
| Serial numbers | 100021, 100052, 100060, 100063, 100066, 100072, 100081, 100094, 100096, 100097, 100100, 100101, 100103, 100112, 100114, 100119, 100121, 100124, 100126, 100187, 100217, 100222, 100236, 100251, 100253 and 475 more |
| Model numbers | U128 |
Product
Model Number U128, VALITUDE CRT-P EL MRI
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-0102-2026. 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.