Abbott Aveir Leadless Pacemaker — Class II medical device recall Z-1695-2024
Ongoing recall by Abbott Medical, reported 2024-05-08, distributed nationwide. Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
| Recall number | Z-1695-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Medical, Sylmar, CA, United States |
| Recall initiated | 2024-02-05 |
| Classified | 2024-04-29 |
| Reported by FDA | 2024-05-08 |
| Distributed | Nationwide (US) |
| Quantity | 10,610 units |
| UPC / GTIN / UDI-DI | 05415067034472 |
| Serial numbers | 1036386, 1301912, 1301916, 1301952, 1301953, 1301958, 1301963, 1301964, 1301965, 1301966, 1301967, 1301968, 1301969, 1301971, 1302859, 1304507, 1304509, 1304519, 1304522, 1304777, 1304788, 1304791, 1304797, 1304799, 1304802 and 475 more |
| Model numbers | LSP112V |
Product
Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
Reason for recall
Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
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-1695-2024. 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.