Recall Z-2880-2020— Biosense Webster (israel), Ltd.

Name: FDA recall Z-2880-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-22

Class II · Terminated

Class II FDA medical device recall by Biosense Webster (israel), Ltd., initiated 2020-06-22, terminated 2022-01-06. It names one FDA 510(k) clearance: K191660. Product: CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure, Product Number: -5400-00, UDI: 10846835000870. Reason: Software defect may result in disapperance of tag sites during recalculation and lead to additional ablation sites. This may lead to prolongation of the procedure and, in extremely rare circumstances, cardiac perforation..

Recalling firm: Biosense Webster (israel), Ltd.
Classification: Class II
Status: Terminated
Initiated: 2020-06-22
Terminated: 2022-01-06
Firm location: Yoqne'Am Illit, N/A, Israel

510(k) clearances named in this recall

1 on FDA's record

K191660 — CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc.·cleared 2019-07-20

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

CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure, Product Number: -5400-00, UDI: 10846835000870

Reason for recall

Software defect may result in disapperance of tag sites during recalculation and lead to additional ablation sites. This may lead to prolongation of the procedure and, in extremely rare circumstances, cardiac perforation.

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