Reported May 8, 2024 · Ongoing

Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO

Abbott Medical

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Abbott Medical · 15900 Valley View Ct · Sylmar, CA · 91342-3577

Is this the product you have?

  • Abbott Aveir Leadless Pacemaker
  • REFLSP112V, STERILEEO
Lot codes and dates
  • UDI05415067034472/
  • Serial Numbers

    4,071 of 4,071 codes

    • 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
Amount recalled
10,610 units

Where it was sold

Why it was recalled

Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:34 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.