FDA Device recall Z-0825-2025
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
- FDA Device
- Class I
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class I recall of ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722) by Boston Scientific, citing 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 n….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0825-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-12-12 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
Reason
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.
Identifiers
| code_info | S702 - UDI-DI: 00802526559358, 00802526576508, 00802526577000, 00802526578106, 00802526578106, Serial Numbers: 100789 1…S702 - UDI-DI: 00802526559358, 00802526576508, 00802526577000, 00802526578106, 00802526578106, Serial Numbers: 100789 100793 100795 100814 100815 100827 100828 100829 100830 100831 100833 100834 100836 100837 100838 100839 100840 100841 100853 100856 100858 100860 100868 100879 100880 100882 100885 100887 100888 100890 100892 100894 100895 100896 100897 100898 100899 100900 100903 100904 100905 100907 100908 100909 100911 100921 100922 100923 100925 100926 100927 100928 100929 100930 100931 100932 100933 100935 100936 100937 100938 100939 100940 100942 100943 100944 100946 700001 700002 700003 700004 700005 700006 700007 700008 700009 700010 700011 700012 700014 700015 700016 700017 700019 700021 700022 700023 700024 700025 700026 700028 700029 700030 700031 700032 700033 700034 700035 700036 700039 700041 700042 700043 700045 700046 700047 700048 700049 700050 700051 700052 700054 700055 700056 700057 700058 700060 700061 700062 700063 700064 700065 700066 700067 700068 700069 700070 |
|---|
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-0825-2025%22
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