Celsius D7TFL252RTRecalls & 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 10846835000429), received between Aug 11, 2023 and Apr 30, 2024 — classified as 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Manufacturing, Packaging or Shipping Problem1
- Material Protrusion/Extrusion1
- Material Twisted/Bent1
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.
MalfunctionApr 30, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND THE MEDICAL TEAM DISCOVERED A BREAK IN THE TIP BEFORE IT WAS USED ON THE PATIENT. UPON ARRIVAL INTO LAB 1, THE FELLOW WHO WAS WORKING IN LAB 2 BROUGHT TO THE MEDICAL TEAM'S ATTENTION THAT THE CELSIUS 4MM CATHETER'S TIP WAS BROKEN. THERE WERE NO EXPOSED WIRES OR INTERNAL COMPONENTS, BUT THE TIP WAS CONFIRMED AS "BROKEN". A NEW CATHETER WAS USED FOR THE PROCEDURE. THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19215196 ↗MalfunctionAug 11, 2023Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion; Material Twisted/Bent; Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion; Material Twisted/Bent
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND THE DEVICE WAS BENT WITH A GAP THAT EXPOSED INTERNAL METALS. IT WAS REPORTED THAT WHEN THE CELSIUS¿ ELECTROPHYSIOLOGY CATHETER WAS REMOVED FROM THE PACKAGING, THE CATHETER WAS DISCOVERED TO BE VISIBLY BENT. THE CALLER STATED THAT THERE WAS A GAP IN THE BLUE MATERIAL ON THE CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND METAL WAS EXPOSED. THEY REPLACED THE CATHETER AND THE PROCEDURE CONTINUED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17511085 ↗
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.