Celsius D7BTCFL252RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835005257), received between Sep 30, 2022 and Nov 8, 2023 — classified as 2 malfunctions.

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

• MalfunctionNov 8, 2023Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion; Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion

  IT WAS REPORTED THAT PRIOR TO A PATIENT'S ABLATION PROCEDURE, THE MEDICAL TEAM DISCOVERED THAT THE CELSIUS¿ ELECTROPHYSIOLOGY CATHETER THEY HAD INTENDED TO USE HAD A PHYSICAL ABNORMALITY AT THE CATHETER'S DISTAL END. THE PHYSICIAN IDENTIFIED THE FOLLOWING ISSUE THROUGH THE PACKING WINDOW: THERE WAS A RIDGE/HUMP AT THE CATHETER'S TIP (PROXIMAL TO ELECTRODES). THE DEVICE WAS NOT USED ON THE PATIENT. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18094586 ↗
• MalfunctionSep 30, 2022Device Contamination with Body Fluid; High Readings; Device Contamination with Body Fluid; High Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND THE BIOSENSE WEBSTER INC. PRODUCT ANALYSIS LAB OBSERVED ELECTRODE #1 AND ELECTRODE #4 INVERTED. INITIALLY IT WAS REPORTED THAT THE CELSIUS¿ ELECTROPHYSIOLOGY CATHETER WAS DEFECTIVE. UPON THE CONNECTION TO THE SMARTABLATE GENERATOR, IMPEDANCE VALUES WERE OFF, EXCEEDING A VALUE OF 250. ABLATION WAS IMPOSSIBLE DUE TO IMPEDANCE CUT OFF OF 250. WHEN WITHDRAWN FROM THE PATIENT, THE CUSTOMER NOTICED A CHARRING LIKE STAIN ON ELECTRODES 3 AND 4. DUE TO THE IMPEDANCE ISSUE AND VISIBLE ERROR ON ELECTRODES, THE CATHETER WAS REPLACED WITH A NEW ONE AND THE PROCEDURE PERFORMED SUCCESSFULLY WITH NEW CATHETER. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED. THE SYSTEM PRESENTED AN ERROR MESSAGE. IMPEDANCE READINGS WERE UNPHYSIOLOGICAL AND GENERATOR PREVENTED ABLATION. THE GENERATOR WAS SET TO TEMPERATURE CONTROL MODE WITH TEMPERATURE CUT OFF AT 95. TEMPERATURE AND POWER WERE NOT PROVIDED. IMPEDANCE EXCEEDED 250. THE PHYSICIAN CONSIDERED THAT THE CHAR WAS EXCESSIVE. THE PHY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15513548 ↗