BIOSENSE WEBSTER recalls PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PEN…

Recall date

April 22, 2020

Source

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

Recall number

Z-2371-2020

FDA classification

Class II

Brand / firm

BIOSENSE WEBSTER

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI IL, VA,, NE, OK, NJ, CT, KS, HI, CO, ND, RI, ID, MS, VT, DC and WV. The count…

Why it was recalled

Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.

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

What was recalled

PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.