N/A (REF 401261)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885825005894), received between Jun 14, 2019 and Aug 14, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Use of Device 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE RV CATHETER KEEPS POPPING OUT OF POSITION - CANNOT GET GOOD THRESHOLD TO MAINTAIN CURVE IN POSITION TO GER STEADY PACING. AS REPORTED, A NEW DEVICE WAS OPENED AND THERE WERE NO ISSUES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION AND NO INFORMATION WAS PROVIDED REGARDING EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809799 ↗
• MalfunctionAug 11, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THE DEVICE WAS FAULTY AS THE CURVE AND DEFLECTION WERE NOT GOOD. THE COMPLAINANT IS NOT AWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17509927 ↗
• MalfunctionJun 14, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THE JSN ELECTROPHYSIOLOGY CATHETER IS FAULTY. THE COMPLAINANT IS UNAWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8700415 ↗