VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
Medical device recall Z-0826-2025. 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?
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
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
U125 - UDI-DI: 00802526559389, 00802526559396, 00802526577109, 00802526578793, 00802526577024, Serial Numbers: 100319 100323 100329 100331 100333 100379 100380 100384 100385 100386 100390 100392 100439 100448 100452 100453 100462 100466…
Every code shown here, 1,994 characters
U125 - UDI-DI: 00802526559389, 00802526559396, 00802526577109, 00802526578793, 00802526577024, Serial Numbers: 100319 100323 100329 100331 100333 100379 100380 100384 100385 100386 100390 100392 100439 100448 100452 100453 100462 100466 100467 100480 100481 100482 100485 100486 100495 100496 100497 100498 100499 100500 100502 100505 100506 100510 100514 100515 100517 100518 100524 100526 100539 100540 100541 100546 100548 100549 100552 100585 100650 100653 100656 100657 100658 100690 100692 100693 100697 100699 100700 100701 100703 100707 100711 100716 100721 100722 100723 100725 100726 100730 100731 100733 100735 100740 100743 100746 100748 100751 100754 100755 100756 100757 100758 100759 100760 100761 100763 100764 100767 100768 100770 100772 100774 100775 100776 100777 100778 100779 100780 100781 100784 100786 100788 100789 100790 100792 100793 100799 100801 100802 100803 100805 100813 100814 100818 100823 100830 100833 100843 100846 100854 100864 100866 100870 100871 100873 100877 100884 100886 100891 100910 100912 700042 700066 700191 700272 700277 700306 700507 700582 700630 700713 700726 700735 700762 700796 700801 700802 700805 700820 700832 700834 700837 700839 700852 700853 700854 700856 700860 700863 700867 700985 701002 701003 701008 701015 701023 701033 701060 701104 701156 701168 701232 701485 701520 701560 701562 701563 701564 701566 701569 701570 701571 701573 701574 701579 701580 701586 701587 701593 701599 701600 701601 701603 701604 701606 701609 701612 701613 701616 701617 701618 701620 701623 701624 701625 701626 701645 701646 701647 701648 701649 701650 701651 701653 701655 701656 701657 701659 701662 701675 701676 701678 701684 701691 701692 701693 701696 701697 701699 701700 701701 701702 701703 701704 701705 701707 701709 701710 701713 701718 701720 701722 701724 701725 701726 701729 701733 701739 701741 701742 701745 701746 701750 701751 701752 701754 701755 701757 701761 701763 701764 701765 701766 701767 701770 701771 701772 701774…
FDA’s list runs to 56,603 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 56,603 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.