NC Emerge® H7493926712500Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729846451), received between Apr 7, 2019 and May 2, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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.

• InjuryMay 2, 2025Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED RESULTING IN EMBOLISM. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED RENAL ARTERY. A 5.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED, AND PART OF THE BALLOON WAS MISSING FROM THE END OF THE CATHETER UPON REMOVAL. ADDITIONALLY, A FRAGMENT OF THE BALLOON SHEARED OFF AND EMBOLIZED INTO THE PATIENT'S RENAL ARTERIES. DETAILS ON FURTHER ACTION FOR THE DETACHED PORTION WERE NOT PROVIDED.

  Patient problems: Embolism/Embolus; Foreign Body In Patient

  MAUDE report 21951438 ↗
• MalfunctionNov 21, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 5.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT OF THE BALLOON CATHETER BROKE WITHIN THE GUIDE CATHETER, AND THE BALLOON BECAME TRAPPED IN THE VESSEL AFTER THE STENT WAS IMPLANTED. ADDITIONALLY, A KINK WAS OBSERVED IN THE MID-SHAFT OF THE CATHETER. THE DEVICE WAS REMOVED BY PULLING IT OUT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE WITHOUT ANY COMPLICATIONS, AND NO PATIENT-RELATED ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746600 ↗
• InjuryAug 25, 2022Difficult 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 RUPTURED, TIP DETACHMENT AND DIFFICULTY IN REMOVAL OCCURRED. A 6F AL1 GUIDE WAS ENGAGED IN THE SAPHENOUS VEIN GRAFT (SVG) TO OBTUSE MARGINAL (OM). A NON BOSTON SCIENTIFIC WIRE WAS ADVANCED TO THE DISTAL PORTION ON THE DRAFT INTO THE OM BRANCH. THE 95% IN-STENT RESTENOTIC LESION WAS DILATED WITH A 2.25 X 15MM BALLOON WIT 60% RESIDUAL. USING A OPTICROSS 60MHZ CATHETER, PERFORMED INTRAVASCULAR ULTRASOUND TO ASSESS THE VESSEL SIZE AND LESION MORPHOLOGY. THEN DILATED AND STENTED A DOWNSTREAM LESION IN THE OM BRANCH, ULTIMATELY PLACING A NON BOSTON SCIENTIFIC STENT IN THE OM, POST-DILATED TO 3.0MM WITH EXCELLENT ANGIOGRAPHIC RESULT. RETURN TREATMENT OF THE PROXIMAL GRAFT IN-STENT RESTENOTIC LESION, USING A 3.5 X 15MM NC BALLOON TO DILATE THE LESION AT HIGH PRESSURE WITH 30% RESIDUAL. A NON BOSTON SCIENTIFIC STENT WAS PLACED TO COVER THE PROXIMAL GRAFT STENOSIS AND POST DILATED WITH A 5.00MM X 12MM NC EMERGE BALLOON CATHETER , HOWEVER, DURING PROCEDURE AT 20 ATMOSPHERES THE BALLOON RUPTURED. TRIED TO REMOVE THE BALLOON, BUT IT WAS STUCK IN THE GUIDE TIP. VISUALIZATION OF THE BALLOON MARKERS INSIDE THE GUIDE, BUT THERE WAS A FAINT FILLING DEFECT AT THE GUIDE TI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15297852 ↗
• MalfunctionMay 18, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 5.00MM X 12MM NC EMRGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT FRACTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845820 ↗
• MalfunctionApr 7, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURED. A 5.00MM X 12MM NC EMERGE BALLOON CATHETER WAS FOR USE. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8489925 ↗