Recall Z-1591-2016— Biosense Webster, Inc.

Name: FDA recall Z-1591-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-14

Class II · Terminated

Class II FDA medical device recall by Biosense Webster, Inc., initiated 2016-04-14, terminated 2016-10-14. It names one FDA 510(k) clearance: K123837. Product: Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.. Reason: Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves..

Recalling firm: Biosense Webster, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-14
Terminated: 2016-10-14
Firm location: Irwindale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K123837 — PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETERBiosense Webster, Inc.·cleared 2013-03-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.

Reason for recall

Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves.

Data sourced from openFDA. This site is unofficial and independent of the FDA.