PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL…
Medical device recall Z-0823-2025. 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?
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
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
L201 - UDI-DI: 00802526559044, 00802526578014, 00802526576379, 00802526576874, Serial Number: 760500 100707 100788 100793 100800 100803 100804 100808 100838 100839 713123 714640 714796 715611 715757 715779 715795 715799 715802 715805…
Every code shown here, 1,998 characters
L201 - UDI-DI: 00802526559044, 00802526578014, 00802526576379, 00802526576874, Serial Number: 760500 100707 100788 100793 100800 100803 100804 100808 100838 100839 713123 714640 714796 715611 715757 715779 715795 715799 715802 715805 715831 715842 715847 715854 715886 715905 715907 715912 715934 715949 715953 715981 715986 715991 715993 716002 716005 716007 716011 716016 716028 716044 716045 716054 716063 716066 716081 716097 716106 716147 716148 716162 716163 716171 716182 716183 716190 716194 716205 716208 716228 716237 716239 716247 716250 716255 716256 716260 716267 716282 716288 716289 716290 716291 716292 716306 716309 716315 716317 716333 716342 716346 716360 716375 716380 716396 716407 716410 716419 716421 716423 716424 716426 716433 716435 716443 716455 716473 716514 716543 716545 716572 716605 716610 716629 716641 716680 716715 716721 716727 716750 716759 716760 716769 716779 716803 716836 716839 716841 716845 716868 716990 716994 716997 717000 717009 717018 717034 717040 717053 717070 717083 717098 717099 717108 717118 717124 717153 717156 717166 717182 717189 717197 717248 717250 717274 717302 717306 717310 717313 717314 717369 717378 717413 717491 717525 717533 717570 717577 717583 717593 717600 717700 717816 717877 717878 717885 717896 717906 717917 717931 717963 717978 717991 717994 717996 718005 718021 718137 718242 718418 718492 718494 718504 718528 718552 718558 718600 718601 718605 718608 718617 718627 718630 718631 718640 718659 718667 718668 718672 718675 718676 718680 718683 718697 718705 718711 718713 718716 718733 718743 718747 718748 718762 718775 718778 718784 718794 718801 718805 718806 718807 718820 718831 718833 718852 718860 718868 718881 718882 718883 718890 718892 718893 718894 718896 718900 718901 718908 718914 718915 718931 718972 718979 718989 718990 719003 719014 719016 719045 719948 723990 724576 724581 724583 724597 724612 724614 724616 724619 724620 724640 724644 724645 724654 724658 724663 724664 724665 724666 724670 724671…
FDA’s list runs to 201,308 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 201,308 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
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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.