WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation an

FDA device recall Z-1525-2015 · posted 2015-04-27 · Terminated

Recall details

Recalling firm

Biosense Webster, Inc.

Reason for recall

The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.

Action taken

A recall letter dated 4/17/15 will be sent to customers by FedEx to inform them that Biosense Webster is recalling Webster HIS catheter, 4Pole Fixed Curve with Auto ID (Catalog No. D1085413). The letter informs the customers of the problems identified and the actions to be taken. Customers with questions related to the recall letter are instructed to contact their Biosense Webster sales representative or call (866) 473-7823, Monday through Friday from 7:00AM to 8:00PM EST. Customers with questions related to the Voluntary Recall Certification Form and the process for returning the form, are instructed contact Elie Ghattas, Field Action Coordinator, at (909) 839-7281.

Root cause

Software Manufacturing/Software Deployment

Status

Terminated

Product code

DRF

Quantity affected

503 units

Distribution

US nationwide distribution.

Date initiated

2015-04-17

Date posted

2015-04-27

Date terminated

2015-12-10

Location

Irwindale, CA