Celsius D7TCDL252RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10846835000382), received between Mar 31, 2020 and Aug 22, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Body Fluid” (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND THERE IS SOME OF THE BLUE PLASTIC COATING MISSING AT THE TIP. THE TIP OF THE CELSIUS¿ ELECTROPHYSIOLOGY CATHETER SHOULD BE STRAIGHT, BUT THIS CATHETER THE TIP IS BENT. IN ADDITION, THERE IS SOME OF THE BLUE PLASTIC COATING MISSING AT THE TIP. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. THE CALLER DID NOT SUPPORT THIS CASE. IT WAS A CASE PERFORMED BY THE PHYSICIAN WITHOUT SUPPORT BY THE BIOSENSE WEBSTER, INC. TEAM. THAT IS WHY THE CALLER CANNOT PROVIDE THE SPECIFIC DAY OF PROCEDURE. BUT THE CALLER IS SURE THAT THEY PERFORMED THE PROCEDURE ONLY A FEW DAYS BEFORE THE CALLER RECEIVED THE CATHETER WITH THE ISSUE. THERE WERE NO WIRES EXPOSED. THE TIP WAS JUST BENT LIKE IT WAS KIND OF PRE-SHAPED, COMPARABLE FOR EXAMPLE LIKE THE CARDIAGUIDE IS PRE-SHAPED WITH AN ANGLE. AS THERE WAS SOME OF THE PLASTIC COATING AT THE CATHETER TIP MISSING, SOME OF THE ELECTRODES WERE MORE EXPOSED THAN THEY SHOULD BE. THE CALLER BELIEVES THEY SAW THE DAMAGE BEFORE INSERTION OF THE CATHETER. THE CALLER ALREADY SENT THE CATHETER IN AND THEREFORE, UNABLE TO TAKE A PICTURE. THE CATHETER W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595887 ↗
• MalfunctionSep 11, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER. THERE WAS IMPROPER MARGINS BETWEEN ELECTRODE 2 AND 3. THERE WAS AN IMPROPER SHAFT SURFACE, IN BETWEEN ELECTRODE 2 AND 3. CATHETER WAS NOT INSERTED INTO THE PATIENT TO AVOID ANY POSSIBLE DAMAGE. THERE WAS A ROUGH BUMP VISIBLE IN BETWEEN ELECTRODE 2&3. THERE WERE NO WIRES EXPOSED AND THERE WAS NO LIFTED OR SHARP RINGS/ELECTRODES/PARTS. NO PATIENT CONSEQUENCES. ELECTRODE DAMAGE WITH SHARP/ROUGH EDGES IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397856 ↗
• InjuryMay 12, 2022Insufficient Cooling; Device Contamination with Body Fluid; Patient Device Interaction Problem; Insufficient Cooling; Device Contamination with Body Fluid; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. THE PATIENT HAD A PERICARDIAL EFFUSION ONE HOUR AFTER THE ABLATION. PERICARDIAL DRAINAGE WAS PROVIDED FOR THIS PATIENT WHO WAS STILL IN THE OPERATING ROOM WHEN SHE WOKE UP NOT FEELING WELL. 30 MINUTES WAS ADDED AFTER THE PROCEDURE BECAUSE OF A PERICARDIAL DRAIN. THE PATIENT WAS STABLE AND ALIVE. IT WAS ALSO REPORTED THAT DURING ABLATION, WHILE THE DOCTOR STILL HAD HIS FOOT ON THE PEDAL TO ABLATE, THE ELECTROPHYSIOLOGY RECORDING SYSTEM (EPRS) COUNTED TWO ABLATIONS LIKE ONE ABLATION STOPPED AND ANOTHER ONE RESUMED. THE DOCTOR DIDN'T FEEL THE TWO ABLATIONS AS IT PROBABLY STOPPED AND RESUMED IN 1 OR 2 SECONDS. WHILE THE FOOT PEDAL WAS PRESSED, THERE WAS AN INDICATION STATING THAT THE ABLATION STOPPED, THEN IT RESTARTED. ALSO, AT END OF THE ABLATION, THE TEMPERATURE WAS HIGHER THAN THE TARGET VALUE; THEY WERE ON THE 4ML PRESET. ABLATION STOPPED BECAUSE THE TEMPERATURE EXCEEDED WHAT WAS PROGRAMMED IN THE GENERATOR (TEMPERATURE CONTROL MODE ¿ TARGET 65°C, VALUE OBSERVED AT 72°C).

  Patient problems: Cardiac Tamponade

  MAUDE report 14380206 ↗
• MalfunctionMar 31, 2020Coagulation in Device or Device Ingredient; Insufficient Cooling; Device Contamination with Body Fluid; Coagulation in Device or Device Ingredient; Insufficient Cooling; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR RIGHT FLUTTER ATRIAL FIBRILLATION (AFIB) WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER, AND COAGULUM WAS OBSERVED ON THE TIP OF THE CATHETER. WHILE ABLATING IN THE CAVO-TRICUSPID ISTHMUS THE CATHETER TEMPERATURE WAS GOING UP TO 49 DEGREES. THE GENERATOR WAS ALERTING THE STAFF WHEN THE TEMPERATURE WAS REACHING ABOVE 43 DEGREES. POWER MODE WAS USED. 40W, IMPEDANCE 150-200 OHMS, IRRIGATION WAS 30ML/MIN AND TEMPERATURE WAS RANGING 42-49 DEGREES. THE PHYSICIAN WAS ABLATING FOR MORE THAN FOUR MINUTES. IT IS UNKNOWN IF THE ANATOMY OF THE CAVO-TRICUSPID ISTHMUS IS RIGID. IT IS POSSIBLE THAT THE CATHETER WAS GETTING STUCK IN A POUCH WITH ABLATION ON FOR AN EXTENDED PERIOD OF TIME. THIS COULD LEAD TO LIMITED IRRIGATION, CAUSING THE TIP OF THE CATHETER TO OVERHEAT. I SUGGESTED THAT THE CATHETER BE REMOVED TO CHECK FOR CHAR/COAGULUM. AFTER A FEW MORE ABLATIONS THE CATHETER WAS REMOVED AND COAGULUM WAS NOTED ON THE ABLATION CATHETER. THE CATHETER WAS IRRIGATED OUTSIDE OF THE PATIENT AND IRRIGATION WAS FINE. CURRENTLY WAITING ON MORE DETAILS FROM THE TECH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. PLEASE NOTE NO BIOSENSE WEBSTE

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9908864 ↗