medical Class II Updated 2020-06-24

BIOSENSE WEBSTER recalls PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
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.
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