Celsius D7TDL252RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835000412), received between Jan 10, 2022 and Mar 21, 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2024Signal Artifact/Noise; Material Deformation; Signal Artifact/Noise; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND THE DISTAL ELECTRODE¿S PLASTIC PADDING WAS FRAYED. IT WAS REPORTED THERE WERE NO ISSUES WHEN THE CELSIUS¿ ELECTROPHYSIOLOGY CATHETER WAS CONNECTED TO THE SMARTABLATE GENERATOR. WHEN THE PHYSICIAN INSERTED THE CATHETER INTO THE PATIENT¿S BODY WE HAD SEVERE NOISE ON THE DISTAL ELECTRODE SO MUCH SO THAT THE DISTAL ELECTRODE¿S ELECTROGRAMS WEREN¿T DISTINCT AND VISIBLE. THEY TRIED TO DETECT IF THERE WAS ANY ELECTROMAGNETIC INTERFERENCE BUT EVERYTHING SEEMED FINE. THEY CHECKED THE GAIN AND THE SELECTED SETTINGS ON THE RECORDING SYSTEM BUT EVERYTHING SEEMED FINE. THEY REPLACED THE CATHETER¿S CABLE WITH A NEW ONE BUT THE PROBLEM WAS NOT RESOLVED. AFTERWARDS, WE REMOVED THE CATHETER FROM THE PATIENT¿S BODY TO VISUALLY INSPECT THE CATHETER¿S TIP. THEY DETECTED THAT THE DISTAL ELECTRODE¿S PLASTIC PADDING WAS FRAYED AND ALSO THE DISTAL ELECTRODE SEEMED SCRATCHED. FINALLY, WE REPLACED THE ABLATION CATHETER WITH A NEW ONE AND THE PROBLEM EVENTUALLY HAS BEEN SOLVED. THE PROCEDURE CONTINUED WITHOUT ANY FURTHER INCIDENT AND NO HARM TO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956741 ↗
• MalfunctionJan 10, 2022Break; Break

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND THE CATHETER TIP BROKE. IT WAS REPORTED THAT THERE WAS A FRACTURE BETWEEN THE ELECTRODE TIP. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THEY CHANGED THE CATHETER WHEN THE EVENT OCCURRED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE NOT GENERATED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13211610 ↗