THERMOCOOL SMARTTOUCH 의 리콜

Recall

78129

Class 2

Z-0058-2018

2017-09-06

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158833

Biosense webster, inc. has recently received an increased number of complaints related to the display of alert 402 on the carto 3 system for certain lots of thermocool brand catheters. alert 402 implies a "map: magnetic distortion" when connected to carto 3 system. this issue may subsequently lead the physician to ablate in an unintended area when delivering rf energy.

All US and OUS customers, who have purchased the lots identified as part of this recall will be notified via customer letters in order to return the product to BWI facility where it will be segregated for further disposition. This product recall applies to hospitals (or direct customers) and distributors who have purchased and/or received the THERMOCOOL Catheters identified as part of this recall . One notification package which includes the Customer Notification Letter, Business Reply Form (B RF) and pre-paid return label will be distributed to the customers subject to this recall via a 3rd party vendor (Stericycle) for USA. OUS customer communication will occur in accordance with local regulations.