Home / Recalls / Medical Devices
Boston Scientific Corporation recalls VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Recalled October 3, 2018 · FDA recall Z-3259-2018 · Boston Scientific
Hazard
Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion. · FDA Class II
Sold at
AK, AL, AR, AZ, CA, CO, CT, 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, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, W A, WI, WV, and WY
Description
Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
Product
VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →