NC Emerge® H7493926715250Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729846505), received between Sep 4, 2018 and May 7, 2026 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026

  THE EVENT HAPPENED DURING A CTO [CHRONIC TOTAL OCCLUSION] CASE PERFORMED IN CATH LAB B. WE HAD CROSSED A WIRE THROUGH A GRAFT LEADING INTO THE RCA [RIGHT CORONARY ARTERY]. THEN A BALLOON WAS PLACED OVER THE WIRE AND LATER BROKE OFF AND DISLODGED IN THE VESSEL. WE DEPLOYED A STENT IN THE PROXIMITY OF THE BALLOON TO SECURE IT IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111496 ↗
• InjuryAug 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA USER FACILITY REPORT 001159298 THAT BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX CORONARY ARTERY. A 2.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE ANGIOPLASTY PROCEDURE, THE BALLOON DETACHED AND MIGRATED INTO THE CORONARY ARTERY, AND MEDICAL INTERVENTION WAS PERFORMED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22866027 ↗
• MalfunctionMay 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED ARTERY. A 2.50MM X 15MM NC EMERGE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER GUIDE WAS KINKED AT THE HUB AND THE NC EMERGE BURST UPON FIRST INFLATION AT 14ATM WITHIN 15 SECONDS. THE BALLOON WAS REMOVED SUCCESSFULLY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350671 ↗
• MalfunctionMar 25, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 2.50MM X 15MM NC EMERGE WAS ADVANCED FOR DILATION. HOWEVER, DURING THE INSERTION OF THE BALLOON INTO A LAUNCHER GUIDE CATHETER, THE HYPOTUBE BROKE RIGHT ABOVE THE MONORAIL PORTION OF THE BALLOON AND GOT STUCK IN THE GUIDE. THE PHYSICIAN REMOVED THE FRACTURED DEVICE AND THE ENTIRE SYSTEM. A NEW GUIDE CATHETER, GUIDEWIRE AND BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969316 ↗
• MalfunctionAug 12, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. TWO 2.50MM X 15MM NC EMERGE BALLOON CATHETERS WERE USED FOR DILATATION. HOWEVER, UPON INSERTION, BOTH DEVICES WERE FRACTURED PRIOR TO CROSSING THE LESION. IT WAS NOTED THAT THE FIRST DEVICE BROKE CLOSER TO THE WIRE EXIT PORT AND THE OTHER DEVICE BROKE CLOSER TO THE HUB. THE DEVICES WERE REMOVED AND NO FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A 2.5X15 NON-BOSTON SCIENTIFIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15217702 ↗
• MalfunctionAug 12, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. TWO 2.50MM X 15MM NC EMERGE BALLOON CATHETERS WERE USED FOR DILATATION. HOWEVER, UPON INSERTION, BOTH DEVICES WERE FRACTURED PRIOR TO CROSSING THE LESION. IT WAS NOTED THAT THE FIRST DEVICE BROKE CLOSER TO THE WIRE EXIT PORT AND THE OTHER DEVICE BROKE CLOSER TO THE HUB. THE DEVICES WERE REMOVED AND NO FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A 2.5X15 NON-BOSTON SCIENTIFIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15217671 ↗
• MalfunctionNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10NOV2021. IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED. THE PATIENT PRESENTED WITH ISCHEMIA. DURING PREPARATION OF A 2.50MM X 15MM NC EMERGE BALLOON CATHETER AN ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED A SHAFT BREAK AND THAT THE DEVICE HAD BEEN INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12838198 ↗
• MalfunctionJun 18, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION, THE BALLOON RUPTURED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12027042 ↗
• MalfunctionApr 15, 2021Break; Difficult to Insert; Break; Difficult to Insert

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29-MAR-2021. IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 6FR SYSTEM WAS PLACED IN THE PATIENT WITH TWO 0.14 WIRES AND ANOTHER BALLOON CATHETER WERE CROSSED THE LESION. A 2.50MM X 15MM NC EMERGE BALLOON CATHETER WAS USED FOR DILATATION. HOWEVER, THE BALLOON CATHETER SNAPPED OFF WHEN THE PHYSICIAN WAS ATTEMPTING TO INSERT THE IT OVER A 0.14 WIRE. THE DEVICE WAS RETRIEVED AFTERWARDS WITH NO ISSUES. THERE WERE NO PATIENT COMPLICATIONS AND A NEW BALLOON USED THEREAFTER WAS UNEVENTFUL. IT WAS FURTHER REPORTED THAT THERE WAS SOME RESISTANCE DURING INSERTION OF THE 2.50MM X 15MM NC EMERGE BALLOON CATHETER. THE BREAK OCCURRED 3-4 INCHES FROM THE HUB. THE DEVICE ONLY WENT INSIDE THE GUIDE CATHETER, IT WAS THEN TAKEN OUT AND OFF THE WIRE BY HAND BEFORE IT WENT INTO THE BODY. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE SEPARATION OF 67.2CM DISTAL OF THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11675255 ↗
• MalfunctionSep 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.50MM X 15MM AND A 3.00MM X 20MM NC EMERGE BALLOON CATHETERS WERE ADVANCED FOR USE. HOWEVER, DURING INFLATIONS, BOTH BALLOONS WERE RUPTURED AT LOW ATMOSPHERE PRESSURES. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10540718 ↗
• InjuryJul 10, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUE OCCURRED AND PATIENT EXPERIENCED BRADYCARDIA. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED AND INITIALLY INFLATED AT 8 ATMOSPHERES FOR 15 SECONDS WITH A NON-BSC INFLATION DEVICE. HOWEVER, DURING THE SECOND INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON FAILED TO DEFLATE. A SECOND NON-BSC INFLATION DEVICE WAS USED TO DEFLATE THE BALLOON. THE PROLONGED INFLATION CUT OFF BLOOD TO THE DISTAL PORTION OF THE LAD AND THE PATIENT EXPERIENCED SYMPTOMATIC BRADYCARDIA. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH EMERGENCY MEDICATIONS AND CARDIOPULMONARY RESUSCITATION. AFTER THE PATIENT WAS STABILIZED, THE PROCEDURE WAS COMPLETED WITH STENT PLACEMENT IN THE LAD. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT RECOVERED.

  Patient problems: Bradycardia

  MAUDE report 10260876 ↗
• InjuryApr 1, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE AVERAGELY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY. AFTER A STAGED ROTABLATOR, THE LESION WAS DILATED WITH AN EMERGE BALLOON CATHETER WITHOUT ISSUES, BUT UPON REMOVAL FROM THE PATIENT'S BODY THE SHAFT THEN SNAPPED 1/3 FROM THE HUB INSIDE THE 8FR GUIDE CATHETER. THE WIRE WAS PULLED BACK INTO THE GUIDE CATHETER AND SNARED THE BROKEN SHAFT WITHOUT REMOVING THE GUIDE CATHETER. THE LESION THEN DILATED WITH A DIFFERENT BALLOON CATHETER. A 2.50 X 32 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS AND SO ANOTHER BALLOON WAS USED TO PRE-DILATE THE LESION. THE 2.50 X 32 STENT WAS ADVANCED FOR THE SECOND TIME BUT THE SHAFT BROKE AT THE MID PORTION OF THE CATHETER WHILE ADVANCING INTO THE GUIDE. THE STENT WAS PULLED OUT FROM THE GUIDE CATHETER WITHOUT REMOVING THE DEVICE FROM IT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT REMAINED STABLE ALL THROUGHOUT THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9912491 ↗
• MalfunctionJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 03JAN2020. A 2.50MM X 15MM NC EMERGE BALLOON WAS RECEIVED WITH NO ISSUES REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED TIP DETACHMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9617234 ↗
• MalfunctionApr 3, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 15MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE, THE CATHETER SHAFT SNAPPED INTO TWO PIECES OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8477741 ↗
• MalfunctionSep 4, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 15MM BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7842370 ↗