N/A (REF 81531)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885825010157), received between Aug 19, 2019 and Aug 7, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED WHEN THE PHYSICIAN TESTED THE EP CATHETER CURL BEFORE INTRODUCING IT INTO THE PATIENT'S BODY, IT HAD A STRANGE CURVE PROXIMAL. IT WAS REPORTED THERE WAS AN EXTRA CURVE PROXIMAL TO THE PRIMARY INTENDED CURVE. THERE WERE NO NOTED KINKS OR BENDS IN BODY OF CATHETER. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10380549 ↗
• MalfunctionSep 16, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DR. (B)(6) SAID THERE WERE ISSUES WITH THE CURVATURE OF THE ELECTROPHYSIOLOGY CATHETER. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9070574 ↗
• MalfunctionAug 19, 2019Difficult or Delayed Positioning; Material Too Rigid or Stiff; Difficult or Delayed Positioning; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER WAS STIFF AND DIFFICULT TO MANEUVER IN THE PATIENT. AFTER FUSSING WITH IT FOR A SHORT PERIOD OF TIME, THE USER ASKED THAT THIS ELECTROPHYSIOLOGY CATHETER BE REPLACED WITH ANOTHER CATHETER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS ONLY TO REPLACE THE CATHETER. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8908610 ↗
• MalfunctionAug 19, 2019Difficult or Delayed Positioning; Defective Device; Difficult or Delayed Positioning; Defective Device

  IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER WASN'T FUNCTIONING PROPERLY DURING THE CASE. THE MD WAS NOT SATISFIED WITH THE DEFLECTION OF THE ELECTROPHYSIOLOGY CATHETER. THEY TOOK OUT THE ELECTROPHYSIOLOGY CATHETER AND REPLACED IT WITH ANOTHER AND WERE ABLE TO SUCCESSFULLY COMPLETE THE CASE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS APPROXIMATELY 10 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8908494 ↗