VALITUDE CRT-P — Class I medical device recall Z-0826-2025
Ongoing recall by Boston Scientific Corporation, reported 2025-01-22, distributed nationwide. A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an in
| Recall number | Z-0826-2025 |
|---|---|
| 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 | 2024-12-12 |
| Classified | 2025-01-10 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00802526559389, 00802526559396, 00802526559402, 00802526559419, 00802526576522, 00802526577024, 00802526577031, 00802526577109, 00802526578120, 00802526578793, 00802526593284 |
| Serial numbers | 100319, 100322, 100323, 100324, 100326, 100329, 100331, 100333, 100334, 100336, 100338, 100379, 100380, 100384, 100385, 100386, 100390, 100391, 100392, 100439, 100448, 100451, 100452, 100453, 100462 and 475 more |
| Model numbers | U125, U128 |
Product
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
Reason for recall
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
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-0826-2025. 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.