Celsius D7BTCDL252RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10846835005219), received between Oct 20, 2022 and Aug 15, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A CELSIUS CATHETER AND A PIECE OF MELTED MATERIAL WAS ON THE CATHETER TIP. THE PHYSICIAN RETRACTED THE CATHETER FROM THE PATIENT¿S BODY AND NOTICED A PIECE OF MELTED MATERIAL ON THE CATHETER TIP. NO CONSEQUENCE FOR THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 25-JUL-2024. THE DETAILS ON THE FOREIGN MATERIAL IS THAT IT IS PINK, 3MM SIZE, AND ELONGATED SHAPE. THE MATERIAL WAS LOOSE. THE DEVICE WAS USED ON THE PATIENT. RESPONDED YES TO CONFIRMATION IF IT WAS CHAR/CLOT ON THE TIP. ADDITIONAL CLARIFICATION WAS RECEIVED ON 08-AUG-2024 RESPONDING THAT THE REPORTER DOES NOT KNOW IF THE FOREIGN MATERIAL WAS ACTUALLY BIOLOGICAL MATERIAL AND DOES NOT KNOW IF IT IS CHAR. THE ISSUE WAS ASSESSED AS MDR REPORTABLE FOR FOREIGN MATERIAL ON THE USABLE LENGTH OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19997216 ↗
• MalfunctionApr 12, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND A FOREIGN MATERIAL ON THE USABLE LENGTH OF THE CATHETER ISSUE OCCURRED. THE PHYSICIAN COMPLAINED THAT SOME STRANGE MATERIAL (PROBABLY PLASTIC) WAS PRESENT AT THE TIP OF THE CATHETER AND FOR SAFETY REASONS HE DECIDED TO UNPACK A NEW CATHETER. THE SURGERY WAS DELAYED 3 MINUTES DUE TO THE REPORTED ISSUE. THE ACTION TAKEN WHEN THE EVENT OCCURRED WAS TO CHANGE THE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE REPORTER WAS UNABLE TO SEE THE MATERIAL BECAUSE NO CLINICAL SUPPORT WAS PRESENT WHEN THIS OCCURRED. ALL PACKAGING MATERIALS WERE DISCHARGED WHEREAS THE CATHETER WAS SENT BACK. THE CATHETER WAS NOT USED ON THE PATIENT. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR FOREIGN MATERIAL ON THE USABLE LENGTH OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728594 ↗
• MalfunctionOct 20, 2022Product Quality Problem; High Readings; Material Split, Cut or Torn; Product Quality Problem; High Readings; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND IT WAS OBSERVED THAT THE CATHETER DID NOT HAVE A COATING ON THE DISTAL PORTION. THE CATHETER DOES NOT HAVE A COATING ON THE DISTAL PORTION, SO IT DID NOT MARK IMPEDANCES OR IT MARKED HIGH IMPEDANCES. THE SURGERY WAS DELAYED 10 MINUTES DUE TO THE REPORTED EVENT. THE CATHETER WAS CHANGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE MATERIAL WAS CLOSED WHEN RECEIVED AT THE FACILITY. THE FAULT IS IDENTIFIED WHEN USING IT. SHEATH WAS NOT USED. THE DEVICE WAS USED ON THE PATIENT. IN PHYSICIAN¿S OPINION, THE DELAY DID NOT CONTRIBUTE TO A DEATH OR A SERIOUS INJURY TO THE PATIENT. INTERVENTION WAS NOT REQUIRED DUE TO THE DELAY. ABLATION COULD NOT BE GIVEN. TEMPERATURE WAS 50, WATTS 35, AND HIGH IMPEDANCE. ADDITIONAL FOLLOW UP HAS BEEN REQUESTED TO CLARIFY EVENT DESCRIPTION AND REGARDING RESPONSE TO FRAGMENTS QUESTION OF, ¿IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES,¿. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. WITH THE INFORMATION AVAILABLE, THE ISSUE OF THE ¿C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15636816 ↗