Boston Scientific Corporation recalls VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)

Recall date

September 10, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3259-2018

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)