NC Emerge® H7493926712300Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 08714729846390), received between Sep 18, 2018 and Sep 3, 2026 — classified as 13 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Break; Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50599879 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHILE PUSHING THE BALLOON, THE SHAFT FRACTURED AND SEPARATED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574306 ↗
• InjuryMar 5, 2026Difficult to Remove; Material Separation

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED RESULTING IN ADDITIONAL INTERVENTION. THE 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON GOT SNARED ON A STENT AND THE DISTAL END OF THE CATHETER SHEARED OFF IN THE VESSEL. ATTEMPTS WERE MADE TO SNARE THE BROKEN PIECE, BUT THEY WERE UNSUCCESSFUL. ST SEGMENT ELEVATION WAS NOTED, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PHYSICIAN REMARKED THAT THE PATIENT WOULD LIKELY LOSE THAT DIAGONAL ARTERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Foreign Body In Patient; Non specific EKG/ECG Changes

  MAUDE report 24520524 ↗
• InjuryJan 6, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION OCCURRED. THE 100 % STENOSED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.00MM X 12MM NC EMERGE BALLOON CATHETER. HOWEVER, AFTER A SERIES OF TEN INFLATIONS, SUDDEN LOSS OF PRESSURE MOVEMENT OF THE SHAFT WAS OBSERVED DURING BALLOON WITHDRAWAL WHILE THE BALLOON REMAINED IN PLACE, AND THE SHAFT WAS FRACTURED. THE BALLOON WAS SUBSEQUENTLY RETRACTED INTO THE GUIDE, AND THE TIP OF THE GUIDEWIRE WAS MONITORED UNDER FLUOROSCOPY DURING REMOVAL. UPON REMOVAL OF THE GUIDE, THE BALLOON MARKERS WERE NOTED WITHIN THE RADIAL SHEATH. A GUIDEWIRE AND A NEW 2.0 X 8 BALLOON WERE ADVANCED AND INFLATED TO SECURE THE DETACHED BALLOON SEGMENT. THE SHEATH, WIRE, BALLOON, AND FRACTURED SHAFT WERE ALL REMOVED FROM THE BODY. A TR (TRANSRADIAL BAND) BAND WAS APPLIED. NO PATIENT COMPLICATIONS, AND THE PATIENT HAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23984295 ↗
• InjuryMay 6, 2025Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT AND BALLOON RUPTURE OCCURRED REQUIRING TREATMENT. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED, AND IT CAME OFF FROM THE CATHETER. ADDITIONALLY, A PIECE OF THE BALLOON REMAINED IN THE VESSEL WHEN THE CATHETER WAS REMOVED. THE DEVICE STAYED IN PLACE, AND THE PHYSICIAN WAS ABLE TO PASS A WIRE BEYOND THE FRAGMENT. THE FRAGMENT WAS THEN STENTED AGAINST THE VESSEL WALL. THERE WERE NO ADDITIONAL INTERVENTIONS PERFORMED. THE PROCEDURE WAS COMPLETED, AND NO FURTHER ISSUES WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21973286 ↗
• InjuryFeb 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED REQUIRING INTERVENTION. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS MORE THAN 70% STENOSED AND WAS LOCATED IN NON-TORTUOUS VESSEL. A 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. AFTER REMOVAL OF THE DEVICE, IT WAS OBSERVED THAT THE BALLOON FRACTURED AND PART OF IT WAS IN THE OSTIAL RIGHT CORONARY. A GUIDEWIRE WAS USED TO SNARE THE BROKEN PIECE OF THE BALLOON INTO THE GUIDE CATHETER, AND EVERYTHING WAS REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349859 ↗
• MalfunctionJan 31, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 12 ATMOSPHERES FOR 1 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21286854 ↗
• InjuryJun 26, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT A DEFLATION ISSUE AND THROMBOSIS OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED CORONARY ARTERY. A 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON INFLATED TO 12 ATMOSPHERES BUT INITIALLY WOULD NOT DEFLATE, LEADING TO THROMBUS FORMATION WITHOUT PATIENT SYMPTOMS. EVENTUALLY, THE BALLOON DEFLATED ON ITS OWN AFTER 12 MINUTES, AND THE DEVICE WAS REMOVED INTACT. THE SALINE-CONTRAST RATIO USED WAS 50:50. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, AND THE PATIENT'S STATUS WAS STABLE POST-PROCEDURE. NO FURTHER ISSUES WERE REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19617388 ↗
• MalfunctionJun 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. DURING PERCUTANEOUS CORONARY INTERVENTION, A 3.00MM X 12MM AND 3.50MM X 12MM NC EMERGE BALLOON CATHETERS WERE ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, BOTH BALLOONS RUPTURED. THE DEVICES WERE REMOVED WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19520812 ↗
• InjuryApr 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON SNAPPED OFF RIGHT AT PROXIMAL RADIOPAQUE MARKER AND WAS LEFT IN THE PATIENT'S ARTERY UNTIL IT WAS ABLE TO BE SNARED OUT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19148452 ↗
• MalfunctionMar 19, 2024Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT SHAFT BREAK AND BALLOON RUPTURE OCCURRED. A 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST, AND THE SHAFT BROKE. THERE WERE NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18930017 ↗
• MalfunctionMar 8, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. A 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT OF THE BALLOON BROKE. THE BROKEN PART WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER NC EMERGE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18868227 ↗
• MalfunctionFeb 15, 2024Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT SHAFT BREAK AND BALLOON RUPTURE OCCURRED. A 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE SHAFT BROKE AND THE BALLOON BURST. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712977 ↗
• InjuryOct 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED LEFT MAIN (LM) ARTERY. A 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE RUPTURED BALLOON OCCLUDED FLOW IN THE LM AND THE PATIENT WENT INTO PULSELESS ELECTRICAL ACTIVITY (PEA). THE BALLOON WAS REMOVED COMPLETELY, AND THE PROCEDURE WAS COMPLETED WITH A STENT. THE PATIENT STATUS POST-PROCEDURE WAS STABLE.

  Patient problems: Arrhythmia

  MAUDE report 17961597 ↗
• MalfunctionApr 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. A 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USED. HOWEVER, DURING INSERTION THE BALLOON SEPARATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16671213 ↗
• MalfunctionOct 14, 2022Break; Break

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. A 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING INSERTION, THE SHAFT BROKE WHILE PUSHING INTO THE PATIENT'S BODY. BOTH DEVICE PIECES WERE REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW BALLOON. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15607409 ↗
• InjuryAug 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AGENT IDE STUDY. IT WAS REPORTED THAT CORONARY ARTERY DISEASE OCCURRED. ON (B)(6) 2021, THE SUBJECT PRESENTED WITH STABLE ANGINA (CCS CLASSIFICATION: 3) AND THE INDEX PROCEDURE WAS PERFORMED THE SAME DAY. THE SUBJECT WAS ON A PRIOR REGIMEN OF ASPIRIN (>= 72 HOURS) AT THE TIME OF INDEX PROCEDURE. A LOADING DOSE OF 325 MG OF ASPIRIN AND 600 MG CLOPIDOGREL WERE GIVEN PRIOR TO THE PROCEDURE. THE TARGET LESION WAS LOCATED AT THE PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE TARGET LESION WAS PREDILATED WITH 3.0 MM X 12 MM BALLOON WITH 90% RESIDUAL STENOSIS AND TIMI FLOW OF 3. FOLLOWING PRE-DILATION, THE LESION WAS TREATED WITH 3.0 MM X 12 MM NC EMERGE MR BALLOON SUCCESSFULLY, WITH 30% RESIDUAL STENOSIS AND TIMI FLOW OF 3. POST DILATION WAS NOT PERFORMED. IN (B)(6) 2022, THE SUBJECT STARTED EXPERIENCING SHORTNESS OF BREATH, NOT ABLE TO EXERCISE FOR PROLONGED TIME AND MILD CHEST DISCOMFORT AT PEAK EXERTION AND WAS DIAGNOSED WITH CORONARY ARTERY DISEASE. ON (B)(6) 2022, , THE SUBJECT CAME TO HOSPITAL WITH SHORTNESS OF BREATH AND HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. AT THE TIME OF THE EVENT, THE SUBJECT WAS ON ASPIRIN

  Patient problems: Restenosis

  MAUDE report 15228249 ↗
• InjuryJan 26, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON SHAFT SNAPPED LEAVING THE DISTAL PORTION OF THE BALLOON SHAFT AND BALLOON STILL IN THE BODY. THE DEVICE WAS PULLED VIA TRAP WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359533 ↗
• MalfunctionJan 20, 2022Break; Break

  IT WAS REPORTED VIA FACILITY MEDWATCH# (B)(4) THAT SHAFT BREAK OCCURRED. A 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT OF THE BALLOON BROKE INSIDE THE PATIENT WHILE STENTING. THE DEVICE WAS REMOVED WITHOUT KNOWN HARM TO PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13309626 ↗
• MalfunctionJan 5, 2022Break

  LATE 60¿S MALE WITH HISTORY OF DIABETES, HYPERTENSION AND PULMONARY EMBOLISM. RESENT SHORTNESS OF BREATH AND TACHYCARDIA. PROCEDURE: HEART CATHETERIZATION, PERCUTANEOUS CORONARY INTERVENTION AND BALLOON ANGIOPLASTY. THE SHAFT OF THE BOSTON SCIENTIFIC NC EMERGE MONORAIL PTCA DILATATION CATHETER BROKE, IN PATIENT, WHILE STENTING. DEVICE REMOVED WITHOUT KNOWN HARM TO PATIENT. ANOTHER CATHETER WAS USED TO FINISH PROCEDURE. MANUFACTURER RESPONSE FOR CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS, NC EMERGE® (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13167908 ↗
• MalfunctionOct 5, 2021Contamination; Packaging Problem; Contamination; Packaging Problem

  IT WAS REPORTED THAT BALLOON CAME OUT OF THE PACKAGE OCCURRED. A 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS PREPARED, HOWEVER, IT WAS OBSERVED THAT THE PACKAGING WAS DAMAGED AND BALLOON CAME OUT OF THE INNER PACKAGE WITH THE TIP POKING OUT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576335 ↗
• MalfunctionSep 24, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DIFFICULTY REMOVING A BALLOON OCCURRED. A LEFT HEART CATHETERIZATION PERCUTANEOUS CORONARY INTERVENTION (LHC/PCI) WAS PERFORMED ON A PATIENT DIAGNOSED WITH CORONARY ARTERY DISEASE (CAD). A 3.00MM X 12MM NC EMERGE BALLOON WAS SELECTED FOR TREATMENT, BUT IT UNABLE TO BE SEEN UNDER FLUORO WHEN INFLATED. IT WAS NOTED THAT THE DEVICE WAS PREPPED APPROPRIATELY WITH CONTRAST SOLUTION, THE ATMOSPHERES HELD ON THE INDEFLATOR WITHOUT ISSUES, AND THE DEVICE WAS PULLED NEGATIVE MULTIPLE TIMES, BUT DIFFICULTY REMOVING THE BALLOON OCCURRED. THE DEVICE WAS REMOVED FROM THE PATIENT, BUT ONCE REMOVED IT WAS NOTICED THAT THE BALLOON WAS STILL PARTIALLY INFLATED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD OR DEVICE. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526668 ↗
• MalfunctionJun 3, 2021Break

  A PATIENT WITH NEW ONSET OF CHEST PAIN WAS ADMITTED FOR A CARDIAC CATHETERIZATION. WHILE REMOVING THE MONORAIL, THE SHAFT BROKE ON A NC EMERGE® PTCA DILATATION CATHETER WITH A BALLOON (3MM DIAMETER AND 12MM LENGTH). ALL PIECES REMOVED WITHOUT KNOWN HARM TO THE PATIENT.

  Patient problems: Chest Pain

  MAUDE report 11929666 ↗
• MalfunctionMay 20, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS USED FOR POST-DILATION. HOWEVER, THE SHAFT BROKE ABOUT HALFWAY DOWN WHILE REMOVING THE DEVICE FROM THE PATIENT'S BODY. THE DEVICE WAS COMPLETELY REMOVED AND NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE SHAFT BROKE ABOUT 20-30CM FROM THE HUB AND WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860933 ↗
• MalfunctionMay 10, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED FOR A STAGED PERCUTANEOUS CORONARY INTERVENTION (PCI). THE HAZY TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED PREVIOUSLY STENTED OBTUSE MARGINAL. A 3.00 MM X 12 MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE SHAFT OF THE BALLOON WAS FRACTURED 6 INCHES FROM THE HUB. THE DEVICE WAS PULLED OUT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797147 ↗