NC Emerge® H7493926720400Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729846697), received between Apr 30, 2021 and Jun 27, 2025 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT CONTAMINATION OCCURRED. A 4.00MM X 20MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. UPON OPENING THE DEVICE PACKAGE, IT WAS NOTICED THAT A PIECE OF RUBBER WAS FOUND ON THE BALLOON SHAFT. THE PROCEDURE WAS COMPLETED VIA AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22351538 ↗
• MalfunctionNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. A 4.00MM X 20MM NC EMERGE BALLOON CATHETER WAS REPORTED WITH NO ALLEGED DEVICE ISSUE. HOWEVER, INVESTIGATION RESULT REVEALED A BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20737803 ↗
• InjuryJun 14, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON BROKE OFF INSIDE THE PATIENT. THE DEVICE WAS SNARED AND REMOVED INTACT FROM THE PATIENT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14685384 ↗
• MalfunctionApr 30, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 4.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. HOWEVER, IT WAS NOTED THAT THE SHAFT WAS FRACTURED. THE DEVICE WAS REMOVED FRACTURED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11751074 ↗