NC Emerge® H7493926712270Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729846383), received between Mar 4, 2019 and Nov 24, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Oct 24, 2019Class IITerminated

   Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.

   Z-0579-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2025Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DEVICE DIFFICULTY REMOVAL AND SHAFT BREAK OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 6F GUIDEZILLA AND 2.75MM X 12MM NC EMERGE BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT NC EMERGE WAS ADVANCE INTO THE GUIDEZILLA, AND AFTER POST DILATING THE STENT, RESISTANCE WAS FELT WHILE REMOVING THE BALLOON. FURTHERMORE, AFTER TAKING THE BALLOON OUT, IT WAS NOTED THAT THE SHAFT WAS BROKEN IN TWO AND THE NON-BOSTON SCIENTIFIC (BSC) 0.014-INCH GUIDEWIRE HAD SHEARED OFF. THE DEVICE WAS REMOVED BY USING ANOTHER 0.014-INCH GUIDEWIRE AND BALLOON AND INFLATED IT TO SNARE OR TRAP THE DISTAL BALLOON SHAFT IN THE BODY. ALL PIECES WERE REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.75 MM X 12MM NC EMERGE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23635712 ↗
• MalfunctionOct 26, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. AFTER PLACING MULTIPLE GUIDEWIRES, A 2.75MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED OVER THE WIRE FOR DILATATION. HOWEVER, DURING INTRODUCTION, THE BALLOON CATHETER SHAFT BROKE OUTSIDE THE PATIENT AND THE DEVICE FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18014114 ↗
• MalfunctionOct 25, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING PREPARATION, A 2.75MM X 12MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, WHILE THE BALLOON WAS LOADING INTO THE WIRE, THE SHAFT BREAK OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666100 ↗
• MalfunctionMar 31, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT LABELING ISSUE OCCURRED. DURING UNPACKING OF A 2.75MM X 12MM NC EMERGE BALLOON, IT WAS NOTED THAT A 3.00MM X 12MM NC EMERGE WAS FOUND INSIDE THE BOX INSTEAD. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13971925 ↗
• MalfunctionJun 24, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.75MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12061407 ↗
• MalfunctionDec 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED VESSEL. A 2.75MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9404017 ↗
• MalfunctionMar 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE HAD OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED ON A MODERATELY CALCIFIED WITH SLIGHTLY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. THE 2.75MM X 12MM EMERGE BALLOON CATHETER RUPTURED ON THE FIRST INFLATION BETWEEN 12 AND 14 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT EMERGE WITHOUT ISSUE OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8388524 ↗