N/A (REF 7003D)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885825008710), received between Jun 18, 2018 and Mar 11, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE. THERE WAS NO PATIENT INJURY AND THE COMPLAINANT IS NOT AWARE OF ANY MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21572190 ↗
• MalfunctionJun 3, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE POLARIS EP CATHETER WAS NOTED TO BE DAMAGED WHEN OPENED. THE CATHETER WAS BENT THEREFORE NOT ABLE TO BE USED AND ANOTHER ONE HAD TO BE OPENED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED REGARDING PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935589 ↗
• MalfunctionMay 20, 2019Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER CAME OUT OF THE PACKAGE WITH A CURLED END. THE STAFF TRIED USING IT IN THE PATIENT, BUT THEY COULDN'T GET IT TO WORK - THERE WAS A DEFLECTION ISSUE. 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 8625897 ↗
• MalfunctionFeb 11, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THERE WAS A DAMAGED ELECTROPHYSIOLOGY CATHETER. THE FLEXOR WAS DAMAGED AT THE TIME THE PACKAGE WAS OPENED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THE COMPLAINANT WAS NOT AWARE OF THE DURATION OF EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8326167 ↗
• MalfunctionOct 4, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER CAME IN BENT AND DID NOT WORK WHEN IT WAS PLUGGED IN. 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 7935497 ↗
• MalfunctionSep 13, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THE CATHETER DOES NOT CURVE CORRECTLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7874622 ↗
• MalfunctionJun 18, 2018Kinked; Difficult To Position; Kinked; Difficult To Position

  IT WAS REPORTED THAT THE TIP OF THE ELECTROPHYSIOLOGY CATHETER WAS KINKED AND COULD NOT GET IN PLACE. 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 7612239 ↗