NC Emerge® H7493926708220Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729846239), received between Jul 29, 2022 and Aug 26, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionAug 26, 2022Break; Break

  IT WAS REPORTED VIA FACILITY MEDWATCH# (B)(4) THAT SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. A 2.25MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE DEVICE BROKE IN HALF WHICH CAUSED ONLY MINIMAL PROCEDURAL DELAY. PHYSICIAN WAS ABLE TO REMOVE THE DEVICE WITHOUT ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15300478 ↗
• MalfunctionJul 29, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK AND PROCEDURAL DELAY OCCURRED. A 2.25MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE CATHETER BROKE IN HALF WHILE USING IN THE PATIENT. IT WAS NOTED THAT THE EVENT ONLY CAUSED MINIMAL PROCEDURAL DELAY. THE DEVICE WAS REMOVED WITHOUT ANY HARM TO THE PATIENT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15129523 ↗