FDA Medical devices recall ·
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722) recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0825-2025
- Date
- (initiated December 12, 2024)
- Company / brand
- Boston Scientific Corporation
4100 Hamline Ave N, Saint Paul, MN, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 156,329 units (59,937 US, 96,792 OUS) in total
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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 700071 700072 700073 700074 700075 700076 700078 700079 700080 700081 700082 700083 700084 700085 700086 700087 700088 700089 700090 700091 700093 700094 700095 700097 700098 700099 700100 700101 700102 700103 700104 700105 700106 700107 700108 700109 700110 700111 700112 700113 700114 700115 700117 700118 700119 700120 700121 700122 700124 700125 700126 700127 700128 700129 700130 700131 700132 700133 700134 700136 700138 700139 700140 700141 700142 700143 700144 700145 700146 700147 700148 700
Distribution
US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
States: Puerto Rico
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0825-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.