Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI Recalled by Abbott Medical Due to Due to a manufacturing issue, leadless pacemakers may...

Date: February 15, 2025
Company: Abbott Medical
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Medical directly.

Affected Products

Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 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.

Quantity: 6 devices

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Abbott Medical

Abbott Medical has 42 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report