# P980003: Chilli Cooled RF Ablation System

- Pathway: PMA
- Applicant: Boston Scientific Corp
- Decided: Feb 2, 1999 after 368 days
- Product code: LPB (Cardiac Ablation Percutaneous Catheter)
- Device class: 3
- Recalls of this device: 4 (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
- Jun 20, 2018 · Class II · Z-0202-2019: Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.
- Sep 27, 2010 · Not classified · Z-0170-2011: Boston Scientific is conducting a Recall on CircuCool Tubing Sets used with the Chilli II Cooled Ablation System because there may be a potential for a sterile barrier breach which could compromise de
- Sep 22, 2009 · Not classified · Z-1156-2010: Product failure-- Product may cease operation as a result of potential speed control board failure when the device is shut off, and may not turn back on. A component on the circuit board fails unexpec
- Dec 30, 2005 · Not classified · Z-0473-06: Product is mislabeled with the incorrect catheter curve description.

Source page: https://510kreport.com/device/P980003
Methodology: https://510kreport.com/methodology