# P990071: Stockert 70 Radiofrequency Ablation Generator

- Pathway: PMA
- Applicant: Biosense Webster, Inc.
- Decided: May 31, 2000 after 204 days
- Product code: LPB (Cardiac Ablation Percutaneous Catheter)
- Device class: 3
- Recalls of this device: 3 (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 6, 2017 · Class II · Z-0058-2018: 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 impli
- Jul 7, 2011 · Not classified · Z-3178-2011: Biosense Webster has initiated a voluntary field notification to all customers that have a Stockert 70 Radio Frequency Generator, to communicate undetected software anomalies in the form of software r
- Jul 16, 2004 · Not classified · Z-1328-04: Generator Failure resulting increase of catheter temperature that could not be controlled by power reduction.

Source page: https://510kreport.com/device/P990071
Methodology: https://510kreport.com/methodology