NC Emerge® H7493926708200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729846222), received between Oct 27, 2022 and Apr 16, 2024 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionApr 16, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT A DEFLATION ISSUE OCCURRED. DURING THE PROCEDURE, A 2.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTICED THAT THE BALLOON WAS DEFLATED SLOWLY. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122255 ↗
• MalfunctionApr 15, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON SLOW DEFLATION OCCURRED. A 2.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON DEFLATED SLOWLY. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19111872 ↗
• InjuryOct 27, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT A SHAFT BREAK AND REMOVAL DIFFICULTY OCCURRED, REQUIRING SURGICAL INTERVENTION. A 2.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, POST-DILATATION, THE BALLOON WAS DIFFICULT TO REMOVE FROM THE STENT AND IT WAS NOTED THAT THE HYPOTUBE TORE. THE DEVICE WAS NOT REMOVED INTACT, AND THE PATIENT HAD TO GO TO SURGERY. THE PROCEDURE WAS NOT COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15682667 ↗