Boston Scientific Corporation recalls ALTRUA 2 DR Pacemaker
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
Lot / code information
- UDI
- 00802526559358, 00802526576508, 00802526577000, 00802526578106, 00802526578106
- Serial #
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 1008…Show all
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 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UDI
- 00802526559372, 00802526576515, 00802526578113, 00802526593239
- Serial #
100037 100038 100039 100040 100041 100042 100044 100046 100047 100048 100049 100050 100053 100054 100055 100056 100057 100059 100060 100061 100067 100068 100070 100071 100072 100073 100075 100076 1000…Show all
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What the firm is doing
The firm sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2024. The letter describes the product, problem and actions to be taken. The customers were instructed to promptly identify patients, if device enters Safety Mode, perform emergent replacement for patients who are at risk for harm, during replacement of a device in Safety Mode pacing inhibition should be anticipated during electrocautery. General prophylactic replacement is not recommended; schedule device replacement promptly when the longevity remaining reaches four (4) years or if the longevity remaining is less than 4 years, perform system follow-ups in accordance with the instructions for use and update patients records with letter to maintain awareness for the remaining service life of the device. If you have any questions regarding this information or would like to report a clinical event, contact your Boston Scientific representative or Technical Services. Supplement March 26, 2025, High-Level Overview of Recall Strategy: on 03/26/2025, BSC notified only those implanting and following clinicians responsible for the newly identified active advisory devices. The letter sent to these clinicians will be the original December 12, 2024, Product Advisory letter, however, the March 2025 communication included a cover letter stating that new devices were identified that should have been initially categorized in the Advisory population.
DistributionShow detailsHide
US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0825-2025
- FDA device classification · LWPOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Boston Scientific CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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