NC Emerge® H7493926715270Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729846512), received between Aug 27, 2018 and Nov 18, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR A TARGET LESION LOCATED IN THE CORONARY ARTERY. A 2.75MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE THE SHAFT BROKE WHEN ATTEMPTING TO ADVANCE INTO THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE DEVICE WAS REMOVED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584558 ↗
• MalfunctionApr 21, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. THE 85% STENOSED, 2.9MMX28MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING INSERTION, THE DEVICE DELIVERY SHAFT WAS FRACTURED, AND THE BALLOON TUBE HAD A KINK MARK. THE BALLOON WAS WITHDRAWN FROM THE BODY AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873646 ↗
• MalfunctionApr 8, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING PREPARATION, A 2.75MM X 15MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USED. AFTER REMOVING THE DEVICE FROM THE HOOP, THE BALLOON CATHETER WAS FRACTURED. THE DEVICE NEVER WENT INTO THE PATIENT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19064776 ↗
• MalfunctionOct 27, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING. A 2.75MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INTRODUCTION, THE SHAFT BROKE OUTSIDE THE BODY. THE DEVICE WAS REMOVED MANUALLY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18019951 ↗
• InjuryAug 12, 2022Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE, BALLOON DETACH AND UNRETRIEVED DEVICE FRAGMENT LEAD TO ADDITIONAL SURGERY OCCURRED. THE TARGET LESION WAS LOCATED IN THE VERY CALCIFIED DIAGONAL BRANCH. A 2.5X20 EMERGE BALLOON CATHETER WAS ADVANCED AND INFLATED AT 10ATMOSPHERES (ATM). A 2.5X26 NON-BOSTON SCIENTIFIC (BSC) STENT WAS THEN PLACED IN THE LESION AND POST-DILATED WITH A 2.5X15 NC EMERGE BALLOON CATHETER TWICE AT 25 ATM. THE BALLOON WAS REMOVED AND THEY PROCEEDED TO TREAT THE LESION WITH SHOCKWAVE AND A 2.5X15 WOLVERINE CUTTING BALLOON. A 2.75X15 NC EMERGE BALLOON CATHETER WAS THEN ADVANCED AND INFLATED AT 22 ATM FOR 100 SECONDS. HOWEVER, THE BALLOON RUPTURED AND WHEN THE BALLOON WAS DEFLATED, THEY SUSPECTED A POSSIBLE DISSECTION. UPON REMOVING THE BALLOON THEY REALIZED THAT PART OF THE BALLOON WAS LEFT IN THE PATIENTS BODY. SNARING THE REMAINS OF THE BALLOON WAS TRIED BUT UNSUCCESSFUL. THE PATIENT WAS THEN TAKEN TO SURGERY FOR A TRIPLE BYPASS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; Vascular Dissection

  MAUDE report 15217748 ↗
• MalfunctionJan 12, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE SHAFT BROKE AT THE MIDDLE PORTION BEFORE ENTERING THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11155327 ↗
• MalfunctionDec 15, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75MM X 15MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE, HOWEVER, THE BALLOON WAS BROKEN AFTER TAKEN OUT FROM THE BOX. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 11007699 ↗
• InjuryJan 16, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY WAS ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CIRCUMFLEX ARTERY. DURING A BIFURCATION KISSING BALLOON TECHNIQUE OF THE FIRST OBTUSE MARGINAL AND CIRCUMFLEX ARTERIES, A 2.75MM X 15MM NC EMERGE BALLOON CATHETER BECAME STUCK IN THE CIRCUMFLEX ARTERY. ATTEMPTS WERE MADE TO REMOVE THE BALLOON; HOWEVER, THE PATIENT WAS SENT TO SURGERY TO HAVE THE BALLOON REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Code Available

  MAUDE report 9597859 ↗
• InjuryOct 22, 2019Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE AND DIFFICULTY REMOVAL WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.75MM X 15MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE BALLOON POPPED AND GOT STUCK IN THE STENT AREA OF LAD. PHYSICIAN TRIED TO USE A GUIDE EXTENSION CATHETER AND PULLED NEGATIVE BUT THE BALLOON WAS STILL UNABLE TO BE REMOVED FROM THE VESSEL. AFTER THE BALLOON BEING PULLED, THE BALLOON DETACHED AND WAS STENTED TO THE VESSEL WALL. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 9219065 ↗
• MalfunctionOct 21, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING ROUTINE PUSHING OF A 2.75MM X 15MM NC EMERGE BALLOON CATHETER OVER THE WIRE THROUGH THE GUIDE, THE SHAFT BROKE IN HALF WHILE THE DEVICE WAS STILL OUTSIDE THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9215772 ↗
• MalfunctionAug 21, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75MM X 15MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE TIP OF THE BALLOON WAS FOUND TO BE BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED AND THE OUTCOME OF THE PROCEDURE WAS SUCCESSFUL.

  Patient problems: No Patient Involvement

  MAUDE report 8917783 ↗
• MalfunctionAug 27, 2018Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75MM X 15MM NC EMERGE BALLOON CATHETER WAS INSERTED OVER THE WIRE. HOWEVER, THE DEVICE EXPERIENCED DIFFICULTIES ADVANCING THROUGH THE GUIDE CATHETER PRIOR REACHING THE CORONARY ANATOMY. THE NEGATIVE WAS PULLED FROM THE BALLOON AND BLOOD WAS NOTED IN THE CONTRAST. SUBSEQUENTLY, THE BALLOON WAS COMPLETELY REMOVED FOR FURTHER INSPECTION AND IT WAS NOTED THAT THE SHAFT WAS BROKEN OR SNAPPED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818935 ↗