Celsius D7TCFL252RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10846835000405), received between Nov 24, 2021 and Mar 22, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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.

• MalfunctionMar 22, 2024Material Protrusion/Extrusion; Material Twisted/Bent; Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND WHEN OPENING THE PACKAGE, UPON VISUAL INSPECTION, THE CATHETER APPEARED DEFECTIVE ON THE CATHETER TIP, JUST BELOW PROXIMAL ELECTRODES. THERE WAS A BEND AT THE DISTAL PORTION AND BRAIDING EXPOSED. THE CATHETER WAS NOT INSERTED IN PATIENT. THE CATHETER WAS REPLACED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18957051 ↗
• MalfunctionSep 18, 2023Positioning Failure; Material Protrusion/Extrusion; Positioning Failure; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER. AFTER CONNECTING THE CATHETER TO A ST. JUDE MEDICAL RADIOFREQUENCY (RF) GENERATOR AND RECORDING SYSTEM, THE PHYSICIAN INSERTED THE CATHETER INTO THE PATIENT. SOMETHING ABNORMAL WAS SEEN ON THE XRAY SO THE PHYSICIAN REMOVED THE CATHETER FROM THE PATIENT. THE PHYSICIAN DEFLECTED THE CATHETER, AND THE CURVE APPEARED ABNORMAL. WHEN CHECKING THE CATHETER CLOSELY, IT APPEARED TO BE DEFECTIVE. THE CATHETER IS NOT COATED AND WIRES CAN BE SEEN. THERE WERE NO LIFTED NOR SHARP RINGS AND THERE WAS NO RESISTANCE DURING INSERTION AND REMOVAL OF THE CATHETER. THE ISSUE WITH THE CURVE OF THE CATHETER WAS ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. THE WIRES EXPOSED ISSUE IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765937 ↗
• MalfunctionNov 24, 2021Break; Break

  IT WAS REPORTED THAT AN UNKNOWN PATIENT HAD A FAILED CELSIUS¿ ELECTROPHYSIOLOGY CATHETER IN ITS ISOLATION NEAR THE PROXIMAL ELECTRODES WHERE A CUT WAS SEEN IN ITS SILICONE COATING. IT WAS REPLACED BY ANOTHER CELSIUS CATHETER. THE PROCEDURE WAS UNEVENTFUL WITH NO DELAY AND THERE WAS NO HARM TO THE PATIENT. THE DEVICE WAS IN HOSPITAL¿S POSSESSION AND NOT EXPECTED TO BE RETURNED. BROKEN TIP IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12872888 ↗