Celsius D8BTDL252RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835006612), received between Jun 16, 2017 and Jun 16, 2017 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2017Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A CELSIUS CATHETER AND A DEFLECTION ISSUE OCCURRED AS THE CATHETER COULD NOT DEFLECT AS INTENDED. THE CATHETER WAS CHANGED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE SINCE THE CATHETER IS UNABLE TO DEFLECT OR RELAX COMPLETELY; THE USER WILL NOT BE ABLE TO USE THE DEVICE AND WILL HAVE TO REPLACE IT. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. ON (B)(6) 2017, DURING THE VISUAL INSPECTION AT THE BIOSENSE WEBSTER FAILURE ANALYSIS LAB, IT WAS DISCOVERED THAT DAMAGE WAS FOUND ON THE WINDOW BETWEEN RINGS 2 AND 3 OF THE CATHETER. THERE WAS NO REPORT OF ANY DIFFICULTY WITHDRAWING THE CATHETER OR PRE-SHAPING THAT MAY HAVE CAUSED THIS DAMAGE. IN ADDITION, THIS FINDING WAS NOT REPORTED TO HAVE BEEN NOTICED PRIOR TO USE, UPON WITHDRAWAL FROM THE PATIENT OR PRIOR TO SENDING THE CATHETER BACK FOR ANALYSIS. THIS FINDING WAS ASSESSED AS MDR REPORTABLE BECAUSE THE DAMAGE HAS CREATED A BREAK IN CATHETER INTEGRITY THAT CREATES THE RISK OF INTERNAL PARTS BEING EXPOSED. THE RISK TO THE PATIENT IS CRITICAL DUE TO TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6646670 ↗