Dual Energy Thermocool Smarttouch SF Catheter D134814Recalls & reported problems
Biosense Webster Inc · THMCL SMTCH SF DE, BI,TC, F-J · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835026887), received between Sep 29, 2026 and Sep 29, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
8 other recalls cover devices cleared under the same FDA submission (P030031); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Cardiac Tamponade1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Patient Device Interaction Problem
Patient problems: Cardiac Tamponade
MAUDE report 50939120 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P030031. One submission often covers many models, so check the product and lot details in each record.
- Z-0169-2023 · Sep 7, 2022 · Open, ClassifiedTHERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in con
- Z-0139-2015 · Oct 19, 2014 · TerminatedThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
- Z-0979-2012 · Nov 22, 2010 · TerminatedEZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
- Z-0981-2012 · Nov 22, 2010 · TerminatedEZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
- Z-0982-2012 · Nov 22, 2010 · TerminatedEZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
- Z-0983-2012 · Nov 22, 2010 · TerminatedEZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
- Z-0980-2012 · Nov 22, 2010 · TerminatedEZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
- Z-0057-06 · Aug 8, 2005 · TerminatedThermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L-1189-01-S D17TCBLRT 35Q-13R PMA; L-1189-02-S D17TCDLRT 35Q-33R PMA; L-1189-03-S D17TCFLRT 35Q-53R P
Other Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation devices
- FARAWAVE™ M004PF41M401Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 recall39 deaths1,515 reports
- PulseSelect™ PSCC100Medtronic, Inc. · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation3 deaths496 reports
- FARAWAVE™ NAV M004PF41M411Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation11 deaths417 reports
- VARIPULSE™ Bi-Directional Catheter D141201Biosense Webster Inc · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 recall3 deaths273 reports
- FARAWAVE™ M004PF41M431Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation11 deaths272 reports
- Sphere-9™ Catheter AFR-00001Medtronic, Inc. · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 recall15 reports
- FARAWAVE™ M004PF41M402Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation2 deaths57 reports
- Volt™ PFA Sensor Enabled™ A-VOLT-01St. Jude Medical, Inc. · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation2 deaths38 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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