NC Emerge® H7493926720370Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729846680), received between Sep 26, 2019 and May 9, 2025 — classified as 4 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.

• MalfunctionMay 9, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT MARKER MISALIGNMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 3.75 MM X 20 MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING POST-DILATATION OF THE STENT, IT WAS NOTED THAT THE BALLOON MARKERS APPEARED MISALIGNED, POSITIONED APPROXIMATELY 12 MM APART ON A 20 MM BALLOON RESULTING IN ABOUT 8 MM OF BALLOON OVERHANGING THE MARKERS. THE BALLOON WAS FULLY INFLATED DURING THE PROCEDURE, AND THE MARKERS WERE CLEARLY VISIBLE AND APPEARED CORRECTLY ALIGNED PRIOR TO DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21998599 ↗
• MalfunctionJan 3, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT WAS PRESENTED WITH CARDIOVASCULAR ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN MODERATE TO SEVERELY CALCIFIED AND TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD) AS WELL AS RADIAL ARTERY. A 3.75MM X 12MM, 3.75MM X 20MM, 3.75MM X 12MM, AND 3.75MM X 15MM NC EMERGE BALLOON CATHETERS WERE USED. HOWEVER, THE SHAFT OF THE FOUR CATHETERS WERE BADLY BENT AND BROKEN. THE DEVICES WERE BOTH PULLED OUT INTACT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED DIFFERENT BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16091002 ↗
• MalfunctionJul 8, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN LEFT ANTERIOR DESCENDING ARTERY. A 3.75MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. AFTER BALLOON INFLATION, THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE. HOWEVER, THE DEVICE WAS STUCK ON THE UNKNOWN GUIDEWIRE. BOTH THE BALLOON CATHETER AND THE WIRE WERE PULLED AS A UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14958108 ↗
• MalfunctionSep 26, 2019Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT FROZE ON WIRE OCCURRED. DURING A PROCEDURE INVOLVING A 3.75 X 20MM NC EMERGE BALLOON, THE BALLOON FROZE ON THE WIRE INSIDE THE PATIENT'S BODY. BOTH DEVICES WERE REMOVED TOGETHER. ONCE OUTSIDE THE BODY, THE BALLOON SHAFT FRACTURED AS THE PHYSICIAN WAS TRYING TO REMOVE IT FROM THE WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9126366 ↗