Boston Scientific Corporation recalls ESSENTIO EL DR Pacemaker

Recall date

December 7, 2017

Source

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

Recall number

Z-0371-2018

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, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico Worldwide

Why it was recalled

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

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

What was recalled

ESSENTIO EL DR Pacemaker