Class II

Medical Device Recall: Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO

Abbott Medical · February 5, 2024

Reason for Recall

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

Distribution

US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. OUS: Pending

States Affected

NATIONWIDE

Quantity Affected

10,610 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1695-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.