NC Emerge® H7493926720500Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729846710), received between Aug 11, 2023 and Mar 20, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Material Puncture/Hole

  IT WAS REPORTED THAT SHAFT HOLE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 5.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED ONTO THE GUIDEWIRE. HOWEVER, IT WAS NOTED THE GUIDEWIRE EXITED DISTAL TO THE MONORAIL EXIT PORT. THE BALLOON WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER 5.0 X 20MM NC EMERGE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651066 ↗
• InjuryFeb 26, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT WAS BEING TREATED FOR CORONARY BLOCKAGE. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED VESSEL. A 5.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, AFTER DEFLATING THE BALLOON, THE DEVICE WAS REMOVED FROM THE GUIDE CATHETER AND THE MONORAIL SECTION OF SHAFT BROKE AND SEPARATED FROM THE REST OF THE BALLOON SHAFT. THE PHYSICIAN USED ANOTHER WIRE TO PLACE DOWN PAST THE RETAINED MONORAIL SECTION AND REMOVED THE BROKEN PIECES AND GUIDE CATHETER AT THE SAME TIME, WHILE LEAVING THE SECOND WIRE DOWN. A DIFFERENT BALLOON CATHETER WAS THEN USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18779447 ↗
• MalfunctionFeb 20, 2024Inflation Problem; Difficult to Remove; Inflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED. A 5.00MM X 20MM FG NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, DEVICE FAILED TO INFLATE, RESULTING IN ENTRAPMENT WITH GUIDE AND VESSEL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18740606 ↗
• MalfunctionJan 24, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. A 5.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED TO TREAT CORONARY ARTERY DISEASE. HOWEVER, DURING THE PROCEDURE, THE BALLOON BROKE APART. THE BROKEN PART WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18576270 ↗
• InjuryAug 11, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND NON-TORTUOUS SUPERFICIAL FEMORAL ARTERY. A 5.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE SHAFT OF THE BALLOON CATHETER BROKE APART INSIDE THE PATIENT DURING REMOVAL. THE PHYSICIAN USED A GUIDE CATHETER AND A THREADER DEVICE TO TRAP THE DEVICE FRAGMENT. SUBSEQUENTLY, THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17510864 ↗