Abbott Aveir Leadless Pacemaker
Medical device recall Z-1695-2024. Published in FDA’s Enforcement Report on May 8, 2024.
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 May 8, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 50 states named
- 10,610 units 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 II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
10,610 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 05415067034472/ Serial Numbers: 524933 524932 1301967 1301958 1301969 1301971 1301953 1301965 1301952 1301966 1301916 1301963 1301912 1301968 524931 1304777 1301964 1304509 1304507 1302859 1304519 1304791 1304828 1304815 1304821…
Every code shown here, 1,994 characters
UDI: 05415067034472/ Serial Numbers: 524933 524932 1301967 1301958 1301969 1301971 1301953 1301965 1301952 1301966 1301916 1301963 1301912 1301968 524931 1304777 1301964 1304509 1304507 1302859 1304519 1304791 1304828 1304815 1304821 1304823 1304824 1304522 1304822 1304820 1304829 1304805 1304835 1304836 1304834 1304841 1304837 1304788 1304797 1304802 1304799 1304845 1304854 1304846 1304857 1304852 1304847 1304858 1304868 1304866 1304862 1304870 1304864 1304859 1304856 1304899 1304945 1304959 1304918 1304957 1304906 1304949 1304933 1304911 1304960 1304958 1304903 1304927 1304908 1304919 1304901 1304968 1304962 1304920 1304997 1304931 1305002 1305007 1304884 1304993 1304977 1305000 1304991 1304998 1304994 1304996 1304956 1304982 1304978 1304989 1304990 1304980 1304983 1304984 1304981 1304988 1305018 1305026 1305023 1305010 1305034 1305012 1305005 1305014 1305061 1305083 1305052 1305011 1305084 1305045 1305044 1305040 1305047 1305041 1305053 1305060 1305057 1305043 1305042 1305046 1305054 1305079 1305076 1305068 1305088 1305086 1305056 1305077 1305072 1305069 1305070 1305071 1305074 1305024 1305033 1305067 1305080 1305073 1305062 1305021 1305085 1305173 1305171 1305183 1305172 1305170 1305182 1305236 1305178 1305227 1305176 1305211 1305174 1305180 1305223 1305234 1305230 1305204 1305181 1305224 1305179 1305237 1305203 1305218 1305177 1305175 1305196 1305184 1305215 1305208 1305209 1305219 1305229 1305210 1305217 1305222 1305059 1305442 1305467 1305441 1305435 1305443 1305448 1305463 1305447 1305437 1305438 1305434 1305469 1305445 1305439 1305466 1305461 1305444 1305440 1305462 1305470 1305602 1305647 1305619 1305597 1305624 1305598 1305607 1305618 1305653 1305646 1305660 1305649 1305662 1305655 1305650 1305665 1305658 1305659 1305636 1305669 1305657 1305664 1305465 1305654 1305651 1305617 1306093 1306091 1306111 1306099 1305635 1305663 1306112 1305671 1306081 1306094 1306088 1306090 1306076 1306101 1306085 1306116 1305468 1306105 1306113 1306077 1306082 1306083…
FDA’s list runs to 84,900 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 distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. OUS: Pending
The states and territories these words name
50 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
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 Feb 5, 2024.
- FDA classified it on Apr 29, 2024.
- FDA’s Enforcement Report published it on May 8, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Abbott Medical, of Sylmar, CA.
- 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 84,900 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.