ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI…
Medical device recall Z-0824-2025. 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?
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
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
L101 - UDI-DI: 00802526558924 and 00802526558931, 00802526576317, 00802526576812, Serial Numbers: 100683 100690 100697 100701 100702 100703 100705 100706 100723 100724 100726 100727 100735 100740 100741 100762 100792 101029 101217 101364…
Every code shown here, 1,995 characters
L101 - UDI-DI: 00802526558924 and 00802526558931, 00802526576317, 00802526576812, Serial Numbers: 100683 100690 100697 100701 100702 100703 100705 100706 100723 100724 100726 100727 100735 100740 100741 100762 100792 101029 101217 101364 101367 101370 101385 101392 101404 101408 101425 101428 101441 101480 101498 101499 101512 101558 101566 101570 101578 101595 101624 101673 101680 101694 101716 101721 101724 101731 101732 101742 101747 101757 101774 101775 101777 101784 101793 101799 101801 101810 101813 101830 101832 101836 101845 101854 101859 101860 101861 101863 101865 101870 101871 101874 101880 101898 101902 101903 101914 101921 101933 101936 101939 101950 101952 101956 101960 101961 101969 101971 101976 101993 102000 102001 102005 102021 102029 102037 102038 102041 102046 102060 102062 102069 102075 102077 102099 102103 102120 102127 102168 102174 102181 102212 102219 102225 102234 102249 102272 102275 102402 102403 102412 102433 102457 102466 102504 102537 102541 102568 102600 102607 102615 102616 102627 102645 102648 102650 102660 102679 102681 102684 102686 102693 102698 102707 102722 102723 102747 102749 102754 102757 102758 102763 102772 102784 102790 102793 102804 102807 102809 102813 102818 102819 102824 102831 102835 102849 102851 102857 102905 102918 102932 102934 102938 102939 102940 102941 102947 102951 102972 102975 102982 102983 102989 102995 103004 103006 103015 103017 103020 103081 103083 103095 103102 103106 103116 103120 103127 103135 103145 103147 103151 103156 103157 103162 103171 103178 103179 103186 103188 103192 103194 103197 103217 103220 103223 103235 103237 103238 103240 103242 103245 103246 103250 103251 103253 103256 103263 103266 103287 700047 700056 700058 700064 700066 700067 700072 700073 700074 700076 700080 700083 700090 700104 700105 700117 700161 700206 700207 700236 700284 700295 700331 700338 700383 700386 700397 700400 700441 700481 700482 700506 700548 700549 700550 700637 700645 700651 700764 700769 700779 700789…
FDA’s list runs to 212,183 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 212,183 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.