NC Emerge® H7493926712200Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729846352), received between Sep 10, 2018 and Feb 26, 2025 — classified as 2 injuries, 8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND DISSECTION OCCURRED. THE PATIENT PRESENTED WITH CHEST PAIN AND ANTERIOR ST-ELEVATION. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. ANGIOGRAPHY REVEALED SEVERELY CALCIFIC CORONARY DISEASE WITH A 99% MID LEFT ANTERIOR DESCENDING ARTERY (LAD) STENOSIS WITH TIMI 2 FLOW AND A 99% PROXIMAL LARGE DIAGONAL STENOSIS. A 2.50MM X 12MM EMERGE BALLOON WAS UNABLE TO DILATE THE LAD AT 20 ATMOSPHERES (ATM) BECAUSE OF THE HEAVY CALCIFICATION AND THE BALLOON RUPTURED. A CUTTING BALLOON WAS THEN SELECTED BUT WOULD NOT CROSS THE LESION. A 2.00MM X 12MM NC EMERGE BALLOON WAS SELECTED TO DILATE THE DIAGONAL AND THAT BALLOON RUPTURED AT 12 ATM. A LOCAL DISSECTION IN THE DIAGONAL WAS ALSO NOTED AND A NON-BOSTON SCIENTIFIC (BSC) BALLOON WAS SELECTED TO SUCCESSFULLY DILATE THE LESIONS AT 12-14 ATM. THE LAD WAS THEN STENTED WITH A 2.25 MM X 20 MM SYNERGY DRUG ELUTING STENT AT 18 ATM AND THE DIAGONAL STENTED WITH A 2.25 MM X 12 MM SYNERGY STENT AT 16 ATM. A NON-BSC GUIDE EXTENSION CATHETER WAS USED TO ASSIST IN THE BALLOON AND STENT PLACEMENTS AND THE END RESULT WAS EXCELLENT. THIS WAS A BIFURCATION OR V STENT AND THE LAD STENT HAD TO BE REDILATED AFTER ST

  Patient problems: Vascular Dissection

  MAUDE report 21472450 ↗
• MalfunctionApr 15, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT SLOW DEFLATION OCCURRED. A 2.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON DEFLATED SLOWLY. THE DEVICE WAS REPLACED AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19111711 ↗
• MalfunctionMar 15, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. A 2.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING PROCEDURE, THE BALLOON WAS SLOW TO DEFLATE. THE DEVICE WAS REMOVED IN A FULLY DEFLATED STATE, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918633 ↗
• MalfunctionMar 8, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SHAFT HOLE OCCURRED. THE 70% STENOSED LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 2.00MM X 12MM FG NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INFLATED AT 26 ATMOSPHERES FOR 8 SECONDS WHEN THE LUMEN OF THE CATHETER RUPTURED 6 INCHES PROXIMAL TO THE BALLOON SHOULDER. THE BALLOON WAS REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18870224 ↗
• MalfunctionJan 31, 2023Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED, AND SHAFT KINK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). THE TARGET LESION WAS LOCATED IN THE MILDLY TO MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION AND THE MIDDLE SHAFT WAS BENT. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. A SMALLER NON BOSTON SCIENTIFIC BALLOON CATHETER THEN SEQUENTIAL NC EMERGE BALLOON CATHETER WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE SHAFT WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272096 ↗
• MalfunctionMar 28, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE PROXIMAL PART CLOSER TO THE BALLOON HUB WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A NON BSC PRODUCT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13933337 ↗
• InjuryMay 9, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND VESSEL PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE VENOUS VEIN. A 2.00MM X 12MM NC EMERGE WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON RUPTURED WHEN THE DEVICE WAS INFLATED A LITTLE ABOVE RATED BURST PRESSURE CAUSING A SMALL PERFORATION. THE PROCEDURE WAS STOPPED AND THE PATIENT'S STATUS WAS FINE AND KEPT UNDER OBSERVATION.

  Patient problems: Perforation of Vessels

  MAUDE report 8596657 ↗
• MalfunctionFeb 21, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.00MM X 12MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE SHAFT WAS FRACTURED. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8359543 ↗
• MalfunctionJan 7, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURED. A 2.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON ADVANCING, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8223291 ↗
• MalfunctionSep 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 2.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7861647 ↗