Reported Apr 23, 2025 · Ongoing

Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code:…

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?

  • Aveir DR Leadless Pacemaker (LP) Ventricular
  • Device REF LSP202V UDI-DI code05415067040725
  • REF LSP112V UDI-DI code05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of the heart for monitoring a patient s heart rate and providing rate responsive bradycardia pacing therapy to regulate heart rate
Lot codes and dates
  • Model NumberLSP202V
  • UDI-DI code05415067040725
  • Serial Numbers
    • 1357831
    • 1357869
    • 1357885
    • 1357894
    • 1357895
  • Model NumberLSP112V
  • UDI-DI code05415067034472
  • Serial Number1357956
Amount recalled
6 devices

Where it was sold

Why it was recalled

Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.

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, 4:17 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.