N/A (REF 7000D)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885825008697), received between Dec 12, 2019 and Aug 10, 2021 — classified as 3 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE DEVICE REMAINED DEFLECTED AFTER HANDLE WAS RETURNED TO NEUTRAL. THERE WAS NO 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 12303119 ↗
• MalfunctionFeb 11, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER IS DEFECTIVE; IT IS BENT BY THE ELECTRODES. 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 9693791 ↗
• MalfunctionDec 12, 2019Break; Break

  IT WAS REPORTED THAT THE DEFLECTION ON THE ELECTROPHYSIOLOGY CATHETER WAS BROKEN UPON INSERTION INTO THE SHEATH. 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 9462285 ↗