NC Emerge® H7493926715400Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729846567), received between Feb 22, 2019 and Nov 26, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT OF BALLOON SNAPPED IN HALF. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659202 ↗
• MalfunctionMay 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION BEFORE IT REACHED THE NOMINAL PRESSURE, THE BALLOON BURST. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220940 ↗
• MalfunctionJul 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED VESSEL. A 4.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 16 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17253595 ↗
• MalfunctionMar 8, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 4.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED TO TREAT THE LESION. HOWEVER, UPON PREPARATION, WHILE LOADING INTO THE WIRE, IT WAS NOTICED THAT THE DISTAL PORTION OF THE SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501928 ↗
• MalfunctionOct 6, 2022Material Puncture/Hole; Physical Resistance/Sticking; Material Puncture/Hole; Physical Resistance/Sticking

  IT WAS REPORTED THAT HOLE IN THE CATHETER OCCURRED. DURING PROCEDURE, A 4.00MM X 15MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, WHEN THE BALLOON WAS ATTEMPTED TO LOAD ON A .014 GUIDEWIRE, THE WIRE WOULD NOT FEED THROUGH THE BALLOON LUMEN AND SHAFT HOLE WAS NOTED. A NEW NC EMERGE BALLOON CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15554075 ↗
• MalfunctionMay 5, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 4.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION, HOWEVER, DURING PROCEDURE THE MIDDLE SHAFT SNAPPED. THE DETACHED PORTION WAS REMOVED BY JUST PULLING AND COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291341 ↗
• InjuryNov 23, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED MID CIRCUMFLEX ARTERY. AFTER A STENT WAS INFLATED, A PERFORATION WAS NOTED. THE 4.00MM X 15MM NC EMERGE BALLOON CATHETER WAS INFLATED TWO TIMES FOR 2-3 MINUTES FOR TAMPONADE. THE BALLOON WAS REMOVED AND REINSERTED FOR TAMPONADE TWO MORE TIMES FOR 2-3 MINUTES. WHEN AN ATTEMPT WAS MADE TO REMOVE THE BALLOON AFTER THE FINAL DEFLATION, HEAVY RESISTANCE WAS ENCOUNTERED. THE BALLOON WAS PULLED INTO THE LEFT MAIN WHERE IT WOULD NOT PULL ON THE GUIDE. THE PHYSICIAN PULLED A SECOND TIME AND THE BALLOON SHAFT BROKE AWAY FROM THE BALLOON. THE BALLOON WAS STILL ON THE WIRE AND THE PROXIMAL SHOULDER WAS WEDGED IN THE GUIDE ENOUGH TO REMOVE EVERYTHING AS A WHOLE UNTIL THE ENTIRE SYSTEM BECAME ENTRAPPED IN THE BRACHIAL ARTERY. AN ADDITIONAL WIRE WAS USED AS A BUDDY WIRE NEXT TO THE WIRE/BALLOON THROUGH THE GUIDE TO ASSIST. THE BUDDY WIRE GOT WRAPPED IN THE BALLOON MATERIAL ENOUGH TO ALLOW FOR THE ENTIRE SYSTEM TO BE PULLED OUT OF THE SHEATH. A NEW GUIDE AND WIRE WAS INSERTED AND A COVERED STENT WAS DELIVERED TO THE MID CIRCUMFLEX PERFORATION WITH SUCCESSFUL DEPLOYMENT AND SEAL. THE PATIENT DID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866316 ↗
• MalfunctionAug 26, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. WHILE PREPARING THE 4.00MM X 15MM NC EMERGE BALLOON CATHETER THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374302 ↗
• MalfunctionJun 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 4.00MM X 15MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. DURING INSERTION OF THE BALLOON CATHETER THROUGH THE GUIDER, THE BALLOON NEVER MADE IT PAST THE CURVE OF ARCH. THE PROXIMAL HALF WAS REMOVED AS NORMAL THROUGH THE TOUHY AND VISUALIZED UNDER FLUORO PRIOR TO REMOVAL OF GUIDER AND GUIDEWIRE. THE GUIDER WAS FLUSHED WHICH DID NOT EJECT PORTION OF BALLOON CATHETER. THE DISTAL END REMAINED IN THE GUIDER AND GUIDE/GUIDEWIRE. A GUIDEWIRE WAS INSERTED THROUGH THE GUIDER WHICH PUSHED THE REMAINDER OF THE BALLOON CATHETER OUT OF GUIDER. THE REMAINING PORTION WERE REMOVED AS ONE UNIT. THE TWO PORTIONS OF BALLOON CATHETER WERE INSPECTED AND APPEARED INTACT; THE SHEAR WAS IN MID CATHETER. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NEW 4X15 NC EMERGE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913372 ↗
• MalfunctionOct 12, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.00MM X 15MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE BALLOON RUPTURED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10668060 ↗
• MalfunctionMar 11, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE SHAFT BROKE AND WAS SEPARATED AT THE JUNCTION OF THE HYPOTUBE AND THE DISTAL CATHETER. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. ANOTHER NC EMERGE WITH THE SAME SIZE WAS ADVANCED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9818112 ↗
• MalfunctionFeb 20, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS FIBROTIC PLAQUE WITHIN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST DILATION. HOWEVER, THE BALLOON GOT STUCK ONTO THE WIRE AND WAS NOT ABLE TO BE REMOVED WITHOUT PULLING OUT BOTH DEVICES TOGETHER. AFTER THAT, A NEW 4.00MM X 8MM NC EMERGE BALLOON CATHETER AND A NON-BSC GUIDEWIRE WAS PLACED, BUT AFTER ONE INFLATION BOTH DEVICES GOT STUCK ALSO. AND SO BOTH DEVICES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH A PLACEMENT OF A NEW NON-BSC WIRE INTO THE VESSEL AND IVUS CONFIRMED THAT THE STENT WAS WELL APPOSED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9733566 ↗
• MalfunctionOct 4, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ENTRAPMENT OF A CATHETER AND GUIDEWIRE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, THE DEVICE BECAME STUCK ON THE SAMURAI RC GUIDEWIRE. THE DEVICES WERE REMOVED FROM THE PATIENT'S BODY TOGETHER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9157425 ↗
• MalfunctionFeb 22, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 4.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PREPARATION, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS NOR SERIOUS INJURY WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8364499 ↗