FDA recall Z-1695-2024

Product

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.

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

Key facts

Status

Ongoing

Initiation date

2024-02-05

Report date

2024-05-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sylmar, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1695-2024