ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
Medical device recall Z-0825-2025. Published in FDA’s Enforcement Report on Jan 22, 2025.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 22, 2025. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 156,329 units (59,937 US, 96,792 OUS) in total how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
156,329 units (59,937 US, 96,792 OUS) in total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,994 characters
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 700150 700151 700152 700153 700154 700155 700156 700157 700158 700159 700160 700162 700163 700164 700165 700166 700167 700168 700169 700170 700171 700172 700173 700174 700175 700176 700182 700183 700184 700185 700186 700202 700203 700204 700207 700208 700209 700210 700211 700212 700213 700214 700215 700216 700217 700218 700219 700220 700221 700222 700225 700227 700228 700229 700231 700232 700233 700234 700235 700238 700239 700241 700242 700243 700244 700245 700248 700249 700250 700251 700252…
FDA’s list runs to 17,307 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
The states and territories these words name
- Puerto Rico
- US Virgin Islands
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 12, 2024.
- FDA classified it on Jan 10, 2025.
- FDA’s Enforcement Report published it on Jan 22, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Boston Scientific Corporation, of Saint Paul, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 17,307 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.