Abbott Medical recalls Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05…

Recall date

February 15, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1557-2025

FDA classification

Class II

Brand / firm

Abbott Medical

Sold / distributed

Worldwide - U.S. Nationwide distribution in the states of FL, SC, and WV and the country of Spain. There were five (5) LSP202V devices distributed within the United States (3 in FL, 1 in SC, 1 in WV) that are impacted by this issue, two (2) of which were implanted, see Attachment A.3 for list of se…

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.