Aveir DR Leadless Pacemaker — Class II medical device recall Z-1557-2025
Ongoing recall by Abbott Medical, reported 2025-04-23, distributed nationwide. Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures whi
| Recall number | Z-1557-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Medical, Sylmar, CA, United States |
| Recall initiated | 2025-02-15 |
| Classified | 2025-04-14 |
| Reported by FDA | 2025-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | ES |
| Quantity | 6 devices |
| UPC / GTIN / UDI-DI | 05415067034472, 05415067040725 |
| Serial numbers | 1357831, 1357869, 1357885, 1357894, 1357895, 1357956 |
| Model numbers | LSP112V, LSP202V |
Product
Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of the heart for monitoring a patient s heart rate and providing rate responsive bradycardia pacing therapy to regulate heart rate.
Reason for recall
Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
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-1557-2025. 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.