# P030031: Biosense Webster Navistar/Celsius Thermo Cool Diagnostic/Ablation Deflectable Tip Catheters

- Pathway: PMA
- Applicant: Biosense Webster, Inc.
- Decided: Nov 5, 2004 after 466 days
- Product code: OAD (Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter)
- Device class: 3
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Sep 7, 2022 · Class II · Z-0169-2023: Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insuffi
- Oct 19, 2014 · Class II · Z-0139-2015: The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.
- Nov 22, 2010 · Not classified · Z-0979-2012: Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve lo
- Nov 22, 2010 · Not classified · Z-0980-2012: Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve lo
- Nov 22, 2010 · Not classified · Z-0981-2012: Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve lo
- Nov 22, 2010 · Not classified · Z-0982-2012: Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve lo
- Nov 22, 2010 · Not classified · Z-0983-2012: Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve lo
- Aug 8, 2005 · Not classified · Z-0057-06: Increased complaints regarding catheters with leaks and flow obstruction.

Source page: https://510kreport.com/device/P030031
Methodology: https://510kreport.com/methodology