N/A (REF 81520)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885825010119), received between Jul 1, 2021 and Jul 20, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE EP CATHETER DEFLECTED INTO AN "S" SHAPE ON BACK TABLE WHILE PREPPING FOR THE CASE. NO KINKS OR BENDS WERE NOTED OUT OF PACKAGING. 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 12200468 ↗
• MalfunctionJul 1, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE CUSTOMER CLAIMS THAT THE EP CATHETER DEFLECTED INTO AN "S" SHAPE ON BACK TABLE WHILE PREPPING FOR THE CASE. 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 12104094 ↗