Celsius D7TCEL252RTRecalls & reported problems
Biosense Webster Inc · Class 3
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835006162), received between Aug 25, 2022 and Aug 25, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Most reported problems
Device problems
- Break1
- Signal Artifact/Noise1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2022Signal Artifact/Noise; Break; Signal Artifact/Noise; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER. THE INSULATION IS BROKEN 16MM FROM THE TIP WITH WIRES EXPOSED. IT WAS REPORTED THAT THERE WAS AN INSULATION BREAK NEAR THE PROXIMAL POLES. NO SIGNAL WAS DETECTED ON THE CATHETER, DESPITE CHANGING THE CABLE AND THE GROUNDING PATCH. THEY REPLACED THE CABLE, RADIOFREQUENCY (RF) PATCH AND THE CATHETER. THERE WAS A FIVE-MINUTE PROCEDURAL DELAY. THE DAMAGE RESULTED IN WIRES BEING EXPOSED WITH NO LIFTED OR SHARP RINGS. THERE WAS NO RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER. THE ISSUE OCCURRED 16 MM FROM THE TIP AND THE CATHETER WAS NOT PRE-SHAPED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15291457 ↗
Other Cardiac ablation percutaneous catheter devices
- THERMOCOOL SMARTTOUCH SF D134805Biosense Webster Inc · Cardiac ablation percutaneous catheter1 recall176 deaths4,106 reports
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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