N/A (REF 81404)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885825009915), received between Oct 4, 2021 and Oct 21, 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.

• MalfunctionOct 21, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED, BENT ACUNAV. ONCE THE DEVICE WAS USED AND INSERTED IN THE HEART THE TIP WOULDN'T STEER CORRECTLY AND THE DOCTOR STATED IT MADE A "3" AT THE END WHICH MADE IT INEFFECTIVE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS LESS THAN 30 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674660 ↗
• MalfunctionOct 4, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE CATHETER IS BENT. THE DEVICE WAS REPLACED WITH ANOTHER. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12573660 ↗