Device Recall VOYAGER NC Coronary Dilatation Catheter 의 리콜

Recall

50192

Class 2

Z-0939-2009

2008-11-05

2009-02-03

Terminated

United States

2012-08-13

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74928

The recall was initiated after abbott vascular received reports that, in a small percentage of cases, the protective, yellow balloon sheath of the 4.5mm diameter voyager nc coronary dilatation catheter has been tight. if unnoticed by the user, there is a potential to cause damage to the balloon dilatation catheter during removal of the sheath. the balloon sheath covers the balloon, maintaining th.

An Urgent Device Recall letter (dated November 6, 2008) with an Efficacy Check Reconciliation form was issued and hand-carried to affected customers by their respective Sales Representative who assisted in locating and returning the recalled units. The letter described the problem and informed customers that Abbott Vascular will replace returned recalled product with like product or with VOYAGER NC sizes when they become available. Additionally, customers were instructed to contact their Abbott Vascular local account representative to review their inventory, complete and return the attached Efficacy Check Reconciliation Form and return affected products to Abbott Vascular.