ALTRUA 2 DR Pacemaker — Class I medical device recall Z-0825-2025
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-0825-2025 |
|---|---|
| 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 | 00802526559358, 00802526559372, 00802526576508, 00802526576515, 00802526577000, 00802526578106, 00802526578113, 00802526593239 |
| Serial numbers | 100037, 100038, 100039, 100040, 100041, 100042, 100044, 100046, 100047, 100048, 100049, 100050, 100053, 100054, 100055, 100056, 100057, 100059, 100060, 100061, 100067, 100068, 100070, 100071, 100072 and 475 more |
| Model numbers | S702, S722 |
Product
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
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-0825-2025. 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.