Celsius D7TEL252RTRecalls & reported problems
Biosense Webster Inc · Class 3
All models of Celsius (14)
Data updated Oct 16, 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 10846835006247), received between Apr 21, 2021 and Apr 21, 2021 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
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.
MalfunctionApr 21, 2021Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND A BROKEN TIP OCCURRED. IT WAS REPORTED THAT THE INSULATION (BLUE COATING) WAS DAMAGED ALREADY INSIDE THE PACKAGE. THERE IS A SMALL HOLE (ABOUT 2MM) WHERE THE INNER CABLES CAN BE SEEN THROUGH BECAUSE THERE IS NO BLUE COATING ON THEM. DAMAGE WAS AT THE TIP WHERE THE ELECTRODES ARE LOCATED. HOLE APPROX. 2MM X 1MM IN SIZE, AT THE BLUE ISOLATION. CATHETER WAS NOT TAKEN OUT OF THE PACKAGING. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11700346 ↗
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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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