Recall Z-1695-2024— Abbott Medical

Class II · Ongoing

Class II FDA medical device recall by Abbott Medical, initiated 2024-02-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO. Reason: Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change..

Recalling firm
Abbott Medical
Classification
Class II
Status
Ongoing
Initiated
2024-02-05
Firm location
Sylmar, CA, United States

Product description

Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.