ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI…
Medical device recall Z-0822-2025. 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?
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
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
L301 - UDI-DI: 00802526559174, 00802526559181, Serial Numbers: 100752 100892 100893 100931 100932 100938 100941 100980 100981 100982 100985 100986 100988 100989 100990 100991 100997 101000 101002 101004 101006 101014 101016 101017 101020…
Every code shown here, 1,995 characters
L301 - UDI-DI: 00802526559174, 00802526559181, Serial Numbers: 100752 100892 100893 100931 100932 100938 100941 100980 100981 100982 100985 100986 100988 100989 100990 100991 100997 101000 101002 101004 101006 101014 101016 101017 101020 101021 101022 101024 101025 101033 101036 101037 101042 101043 101044 101046 101048 101050 101053 101059 101061 101067 101214 101218 101221 101223 101224 101225 101382 101388 101393 101400 101406 101409 101411 101412 101418 101423 101424 101427 101436 101438 101440 101442 101450 101454 101455 101457 101459 101466 101469 101472 101475 101492 101493 101494 101511 101523 101524 101525 101529 101533 101535 101537 101541 101543 101545 101546 101550 101553 101555 101559 101560 101564 101572 101575 101576 101577 101579 101581 101584 101585 101588 101590 101602 101603 101604 101605 101607 101609 101611 101619 101625 101633 101634 101637 101638 101640 101642 101644 101648 101654 101656 101659 101676 101684 101687 101700 101705 101706 101726 101741 101749 101767 101779 101788 101790 101796 101805 101823 101825 101841 101844 101851 101852 101873 101889 101911 101912 101919 101930 101931 101938 101941 101942 101951 101953 101955 101966 101967 101968 101982 101987 101988 101992 101998 102010 102011 102014 102022 102023 102025 102033 102034 102036 102039 102040 102042 102047 102057 102058 102068 102070 102073 102076 102079 102080 102081 102084 102085 102087 102089 102091 102095 102096 102098 102101 102104 102112 102115 102118 102125 102129 102138 102142 102144 102147 102148 102152 102153 102154 102156 102157 102160 102164 102167 102172 102176 102183 102184 102185 102187 102188 102191 102198 102201 102203 102205 102207 102209 102210 102211 102215 102222 102223 102237 102247 102248 102250 102252 102257 102260 102263 102264 102269 102278 102283 102284 102289 102291 102297 102301 102302 102308 102309 102310 102311 102316 102325 102327 102331 102332 102338 102342 102348 102350 102352 102353 102355 102356 102360 102361 102362 102363 102365 102370…
FDA’s list runs to 594,970 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 594,970 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.