FDA Device recall Z-1695-2024
Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
- FDA Device
- Class II
- ongoing
- Published 2024-05-08
On 2024-05-08 the FDA classified a Class II recall of Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO by Abbott Medical, citing their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1695-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-05 |
| Published | 2024-05-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abbott Medical |
| Distribution | US |
Product
Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
Reason
Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
Identifiers
| code_info | UDI: 05415067034472/ Serial Numbers: 524933 524932 1301967 1301958 1301969 1301971 1301953 1301965 1301952 1301966 1301…UDI: 05415067034472/ Serial Numbers: 524933 524932 1301967 1301958 1301969 1301971 1301953 1301965 1301952 1301966 1301916 1301963 1301912 1301968 524931 1304777 1301964 1304509 1304507 1302859 1304519 1304791 1304828 1304815 1304821 1304823 1304824 1304522 1304822 1304820 1304829 1304805 1304835 1304836 1304834 1304841 1304837 1304788 1304797 1304802 1304799 1304845 1304854 1304846 1304857 1304852 1304847 1304858 1304868 1304866 1304862 1304870 1304864 1304859 1304856 1304899 1304945 1304959 1304918 1304957 1304906 1304949 1304933 1304911 1304960 1304958 1304903 1304927 1304908 1304919 1304901 1304968 1304962 1304920 1304997 1304931 1305002 1305007 1304884 1304993 1304977 1305000 1304991 1304998 1304994 1304996 1304956 1304982 1304978 1304989 1304990 1304980 1304983 1304984 1304981 1304988 1305018 1305026 1305023 1305010 1305034 1305012 1305005 1305014 1305061 1305083 1305052 1305011 1305084 1305045 1305044 1305040 1305047 1305041 1305053 1305060 1305057 1305043 1305042 1305046 130505 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1695-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.