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Chilli II Cooled Ablation Catheter & Cable

by Boston Scientific

PMA P980003

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

Recall on shared PMA P980003; other models may be affected

Documents

PMA P980003↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP980003 Date19 Jul 2011ApprovedStatusActive

Official records

Recalls

4 recalls · 1 ongoing · FDA

    • Ongoing Z-0202-2019 FDA Class II initiated 20 Jun 2018 on shared PMA P980003

    Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.

    • Terminated Z-0170-2011 FDA Unclassified (pre-2012) initiated 27 Sep 2010

    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 device sterility and potentially the sterile field. Even though there have been no reported complaints.

    • Terminated Z-1156-2010 FDA Unclassified (pre-2012) initiated 22 Sep 2009

    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 unexpectedly because of a power surge, causing a diode to burn out.

    • Terminated Z-0473-06 FDA Unclassified (pre-2012) initiated 30 Dec 2005 on shared PMA P980003

    Product is mislabeled with the incorrect catheter curve description.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Trade name
Chilli II Catheter
Generic name
Cardiac ablation percutaneous catheter
FDA applicant
Boston Scientific Corp
PMA number
FDA product code
LPB
Device class
Class III
Advisory committee
Cardiovascular
FDA decision
APPR Approved
PMA supplement
S029

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Chilli II Cooled Ablation Catheter & Cable is a cardiac ablation percutaneous catheter designed for use in electrophysiology procedures. It is part of the Chilli II cooled ablation system and is intended for use with compatible electrophysiology cables and catheters.

Supplied as a non-sterile, reusable component, the device is used in clinical settings under physician direction. It includes specific models M0046810 and M004620620 for the cable system and is authorized under FDA PMA P980003. Storage and handling should follow manufacturer guidelines for reusable electrophysiology equipment.

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