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Celsius D7TCBL252RTRecalls & reported problems

Biosense Webster Inc · Class 3

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835000368), received between Dec 21, 2018 and Dec 21, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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

Device problems

  • Material Split, Cut or Torn1
  • Sharp Edges1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionDec 21, 2018Material Split, Cut or Torn; Sharp Edges; Material Split, Cut or Torn; Sharp Edges

    IT WAS REPORTED A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND A LOSS OF ELECTRICAL SIGNALS ON SELECT ELECTRODES ISSUE OCCURRED. DURING THE PROCEDURE, THE 1ST AND 2ND ELECTRODES DID NOT HAVE ELECTRIC SIGNAL. THE CATHETER WAS EXCHANGED FOR ANOTHER ONE TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCE WAS REPORTED. THE ISSUE OF LOSS OF SIGNALS ON SELECT ELECTRODES IS NOT MDR REPORTABLE SINCE THE RISK TO PATIENT IS LOW. ON (B)(6) 2018, THE COMPLAINT PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC.¿S (BWI) FAILURE ANALYSIS LAB (FAL) FOR EVALUATION. INITIAL VISUAL ANALYSIS IDENTIFIED, ¿THE TIP LUMEN WAS BENT WITH WHITE STRESS MARKS NEXT TO THE PU MARGIN ON THE DISTAL SIDE OF RING #1 CAUSING DISTAL SIDE OF RING #1 BE EXPOSED AND ROUGH APPROXIMATELY 6.5MM FROM DISTAL END OF THE TIP DOME. WHITE STRESS MARKS FROM THE PROXIMAL SIDE ANCHOR WINDOW APPROXIMATELY 9.5MM FROM DISTAL END OF THE TIP DOME. TIP LUMEN BENT, CRACKED AND ROUGH BETWEEN TIP LUMEN AND PROXIMAL SIDE OF THE ANCHOR WINDOW WITH METAL EXPOSED APPROXIMATELY 9 MM FROM THE DISTAL END TIP DOME. WHITE BUMP ON TIP LUMEN MATERIAL APPROXIMATELY 2 CM FROM DISTAL END OF TIP DOME.¿ THE ISSUE OF EXPOSE

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8192812 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.