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.

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

Code information: This field action includes all lots of the following product codes: D-1282-07, D-1282-08, D-1282-10 and D-1282-11 The other product codes listed in the 806 report for the PENTARAY NAV High-Density Mapping Catheter: D128201, D128202, D128203, D128204, D128205, D128206 are out of scope of this recall because they were not manufactured during the period that is subject to this field action (2016 or later). Product Code Product Description GTIN Number D-1282-01-S PENTARAY¿ NAV, 7FR, F, 4-4-4 10846835009576 D-1282-02-S PENTARAY¿ NAV, 7FR, F, 2-6-2 10846835009583 D-1282-03-S PENTARAY¿ NAV, 7FR, F, 1-8-1 10846835009590 D-1282-04-S PENTARAY¿ NAV, 7FR, D, 4-4-4 10846835009606 D-1282-05-S PENTARAY¿ NAV, 7FR, D, 2-6-2 10846835009613 D-1282-06-S PENTARAY¿ NAV, 7FR, D, 1-8-1 10846835009620 Note - the firm is including the above code information for products that will be distributed to new customers. No Lot Numbers.

Distribution pattern: 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.