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. Thi
Check against the official notice below — it lists the full affected range.
The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is a medical device used to create electroanatomic maps of the heart. This catheter can become entrapped in the cardiac valve apparatus during the mapping procedure. The affected products were distributed worldwide, including across the United States and in countries throughout Europe, Asia-Pacific, Latin America, and Canada. The recall involves product codes D-1282-07, D-1282-08, D-1282-10, and D-1282-11, though no units were actually manufactured from 2016 and later, meaning no products are currently in circulation.
The recall covers catheters that were produced before 2016. Other product codes in the same device family (D128201 through D128206) are excluded from this recall because they were manufactured in 2016 or later. The record does not specify what action affected consumers should take regarding this product.
Written by software from the official notice below. Not reviewed by a lawyer.
Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
Reason for recall: Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map. Distribution: 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 Quantity: 0 units (Products were not manufactured from 2016 and later) Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.