Celsius ThermoCool DI7TCDLRT

• FDA PMA P030031 decided 5 Nov 2004 Active
• FDA GUDID UDI-DI 10846835000443 listed 10 Sep 2014 Listed

• • Ongoing Z-0169-2023 FDA Class II ·initiated 7 Sep 2022

  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) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect.

• • Terminated Z-0139-2015 FDA Class II ·initiated 19 Oct 2014 ·on shared PMA P030031

  The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.

• 5 recalls, same reason

  • Terminated Z-0981-2012 FDA Unclassified (pre-2012) ·initiated 22 Nov 2010 ·on shared PMA P030031
  • Terminated Z-0983-2012 FDA Unclassified (pre-2012) ·initiated 22 Nov 2010 ·on shared PMA P030031
  • Terminated Z-0980-2012 FDA Unclassified (pre-2012) ·initiated 22 Nov 2010 ·on shared PMA P030031
  • Terminated Z-0982-2012 FDA Unclassified (pre-2012) ·initiated 22 Nov 2010 ·on shared PMA P030031
  • Terminated Z-0979-2012 FDA Unclassified (pre-2012) ·initiated 22 Nov 2010 ·on shared PMA P030031

  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 location is a concern, precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode, such as pacing maneuvers. 2. To minimize risk of atrio-esophageal fist

• • Terminated Z-0057-06 FDA Unclassified (pre-2012) ·initiated 8 Aug 2005 ·on shared PMA P030031

  Increased complaints regarding catheters with leaks and flow obstruction.

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

1. 5 Nov 2004 Approved FDA PMA P030031
2. 8 Aug 2005 Recall initiated FDA recalls Z-0057-06
3. 22 Nov 2010 Recall initiated FDA recalls Z-0981-2012
4. 22 Nov 2010 Recall initiated FDA recalls Z-0983-2012
5. 22 Nov 2010 Recall initiated FDA recalls Z-0980-2012
6. 22 Nov 2010 Recall initiated FDA recalls Z-0982-2012
7. 22 Nov 2010 Recall initiated FDA recalls Z-0979-2012
8. 10 Sep 2014 Listed FDA GUDID 10846835000443
9. 19 Oct 2014 Recall initiated FDA recalls Z-0139-2015
10. 7 Sep 2022 Recall initiated FDA recalls Z-0169-2023

Trade name

Celsius ThermoCool

Generic name

Cardiac radio-frequency ablation system catheter

Model / Ref / Catalog

DI7TCDLRT

Primary DI / UDI-DI

10846835000443

PMA number

P030031 ↗

FDA product code

OAD

GMDN term

Cardiac radio-frequency ablation system catheter

Device class

Class III

GUDID distribution status

In Commercial Distribution

Category: Cardiac radio-frequency ablation system catheter

Other devices filed under Cardiac radio-frequency ablation system catheter.

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• Sphere-9™ Catheter AFR-00001 by MEDTRONIC, INC.
• ThermoCool SF BDI35BFRT by Biosense Webster Inc
• ThermoCool SF NAV D131501 by Biosense Webster Inc

• Webster Electrophysiology Catheter

  Class III

  CE/MDD

• TRUPULSE Generator

  Class IIb

  CE/MDR 3903009CE01 Active Valid to Sep 2031

• Carto Vizigo D138505 Open recall

  Class II

  FDA 510(k) K170997 Active Cleared 25 Jul 2017 GUDID on market

• Dual Energy Thermocool Smarttouch SF Catheter D134713 Open recall

  Class III

  FDA PMA P030031 Active Approved 5 Nov 2004 GUDID on market

See all devices from Biosense Webster Inc →