Boston Scientific Corporation recalls ACCOLADE Pacemaker

Recalled October 3, 2018 · FDA recall Z-3257-2018 · 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

ACCOLADE Pacemaker

Manufacturer(s)

Boston Scientific Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →