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

Recalled June 24, 2020 · FDA recall Z-2371-2020 · BIOSENSE WEBSTER

Hazard
Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map. · FDA Class II
Units
0 units (Products were not manufactured from 2016 and later)
Sold at
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 countries of (EMEA, APAC, LATAM, US, Canada) including: NZ,BE,DE,PL,SI,TR,HU,CO,KR,CL,PE,AU,BR,CA,CN,HK,ID,JP,MY,MX,PH,RU,SG,TW,TH,IL,AT,FR,GR,DE,IE,IT,PL,NL,PT,ES,SE,DK,NO,FI,CH,GB,RO,SI,HR,CZ,TR,ZA,AE,BR,ID,BE,PA,CR,CL,NZ,HK,RU,GR,NL,EG,QA,LU,NL,CH,AT,IE,CY. See Attachments 2 & 3 for a distribution list including all domestic and foreign consignees of the device, addresses and phone numbers and the dates and number of devices distributed to each such consignee.

Description

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

Product
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.
Manufacturer(s)
BIOSENSE WEBSTER

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

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