Celsius D7TCL252RTRecalls & reported problems
Biosense Webster Inc · Class 3
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835006209), received between Dec 14, 2023 and Dec 14, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Protrusion/Extrusion2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 14, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND DURING THE PRODUCT CHECK THE PHYSICIAN FOUND ISSUES WITH THE TIP. THE CURVE WAS MORE DRAMATIC THAN USUAL AND THE PHYSICIAN WORRIED THAT IT WOULDN'T REMAIN STABLE DURING ABLATION AND WOULD CONTACT THE ATRIOVENTRICULAR (AV) NODE. THE PHYSICIAN DID NOT USE THIS DEVICE. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18331169 ↗MalfunctionDec 14, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND DURING THE PRODUCT CHECK THE PHYSICIAN FOUND ISSUES WITH THE TIP. THE CURVE WAS MORE DRAMATIC THAN USUAL AND THE PHYSICIAN WORRIED THAT IT WOULDN'T REMAIN STABLE DURING ABLATION AND WOULD CONTACT THE ATRIOVENTRICULAR (AV) NODE. THE PHYSICIAN DID NOT USE THIS DEVICE. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18331131 ↗
Other Cardiac ablation percutaneous catheter devices
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- THERMOCOOL SMARTTOUCH SF D134804Biosense Webster Inc · Cardiac ablation percutaneous catheter44 deaths784 reports
- THERMOCOOL SMARTTOUCH SF D134801Biosense Webster Inc · Cardiac ablation percutaneous catheter15 deaths608 reports
- ThermoCool SmartTouch D132705Biosense Webster Inc · Cardiac ablation percutaneous catheter25 deaths574 reports
- THERMOCOOL SMARTTOUCH SF D134702Biosense Webster Inc · Cardiac ablation percutaneous catheter19 deaths366 reports
- THERMOCOOL SMARTTOUCH SF D134701Biosense Webster Inc · Cardiac ablation percutaneous catheter11 deaths278 reports
- ThermoCool SmartTouch D133602Biosense Webster Inc · Cardiac ablation percutaneous catheter8 deaths225 reports
- SMARTABLATE SAT001Biosense Webster Inc · Cardiac ablation percutaneous catheter185 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.