NC Emerge® H7493926720350Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729846673), received between Dec 13, 2018 and Feb 26, 2026 — classified as 1 death, 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Material Rupture

  IT WAS REPORTED VIA MEDSUN (B)(4) THAT BALLOON RUPTURE OCCURRED AND ADDITIONAL INTERVENTION WAS REQUIRED. THE 3.50MM X 20MM NC EMERGE BALLOON WAS SELECTED FOR USE. THE BALLOON RUPTURED INSIDE THE PATIENT DUE TO CALCIUM. SEVERAL ATTEMPTS WERE MADE TO REMOVE THE BALLOON. AN INTRA-AORTIC-BALLOON PUMP WAS INSERTED, AND THE PATIENT WAS SENT TO SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24457266 ↗
• MalfunctionJun 2, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE HYPOTUBE SNAPPED WHILE BEING INSERTED INTO THE GUIDE. THE DEVICE WAS REMOVED FROM THE GUIDE IN TWO PIECES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126448 ↗
• MalfunctionAug 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE. THE TARGET LESION OVER 80% WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 3.50MM X 20MM NC EMERGE BALLOON CATHETER WAS INTACT UPON REMOVAL FROM THE PACKAGING AND SUCCESSFULLY CROSSED THE LESION. HOWEVER, THE BALLOON RUPTURED PRIOR TO ACHIEVING NOMINAL PRESSURE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076606 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERFORATION OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND IN-STENT RESTENOSIS AND WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A 3.00X20 NC EMERGE BALLOON CATHETER WAS USED TO PRE-DILATE NON-BOSTON SCIENTIFIC STENTS PLACED IN 2006. A 3.00X48MM SYNERGY XD DRUG-ELUTING STENT WAS THEN DEPLOYED. FOLLOWING POST-DILATATION WITH A 3.50MM X 20MM NC EMERGE BALLOON CATHETER, THE PHYSICIAN RECOGNIZED THE PATIENT PULSE RHYTHM HAD CHANGED. UPON INJECTION, A PERFORATION WAS OBSERVED IN THE TARGET LESION. IN THE PHYSICIAN'S OPINION, THE INFLATION CAUSED PLAQUE SHIFT AND ULTIMATELY PERFORATED THE ARTERY. THE PATIENT THEN EXPERIENCED TAMPONADE, CHEST PAIN, AND PREMATURE VENTRICULAR CONTRACTIONS. THE PHYSICIAN PLACED A COVERED STENT AND TAMPED OFF WITH A 3.00X20 EMERGE BALLOON CATHETER. A PERICARDIAL TAP WAS PERFORMED, AND AN ECHOCARDIOGRAM WAS COMPLETED. THE PATIENT WAS CURRENTLY STABLE AND EXPECTED TO RECOVER.

  Patient problems: Arrhythmia; Cardiac Tamponade; Chest Pain; Perforation; Vascular Dissection

  MAUDE report 19975483 ↗
• MalfunctionMay 3, 2024Defective Device; Defective Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23-APR-2024. IT WAS REPORTED THAT DEVICE DAMAGE WAS ENCOUNTERED. UPON OPENING OF A 3.50MM X 20MM NC EMERGE BALLOON CATHETER, IT WAS NOTED THAT THE BALLOON FELL APART AND WAS NOTED TO BE DEFECTIVE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19238108 ↗
• MalfunctionJun 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED VESSEL. A 3.50MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST DILATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 3.50MM X 20MM NC EMERGE BALLOON CATHETER WHICH ALSO RUPTURED DURING FIRST INFLATION AT 10 ATMOSPHERES. THE DEVICE WAS ALSO REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17214096 ↗
• MalfunctionJun 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED VESSEL. A 3.50MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST DILATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 3.50MM X 20MM NC EMERGE BALLOON CATHETER WHICH ALSO RUPTURED DURING FIRST INFLATION AT 10 ATMOSPHERES. THE DEVICE WAS ALSO REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17213447 ↗
• MalfunctionAug 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.50MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER 3.5MM X 20 MM NC EMERGE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266664 ↗
• MalfunctionMar 28, 2022Break; Break

  IT WAS REPORTED VIA FACILITY MEDWATCH#: 0700220000-2022-8026 THAT SHAFT BREAK OCCURRED. A 3.50MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE SHAFT OF THE BALLOON CATHETER SPLIT AFTER PLACEMENT INTO THE PATIENT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13933239 ↗
• MalfunctionFeb 17, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50MM X 20MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING INSERTION, THE BALLOON CATHETER SHAFT SPLIT. THE DEVICE WAS PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER NC EMERGE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13548747 ↗
• InjuryNov 29, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.50MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING REMOVAL, THE SHAFT BROKE OFF AT 24CM FROM THE DISTAL END. THE DETACHED PORTION OF THE DEVICE WAS ATTEMPTED TO BE SNARED BUT WAS UNSUCCESSFUL. THE PATIENT HAD TO UNDERGO AN OPEN HEART SURGERY TO COMPLETELY REMOVE THE DEVICE FRAGMENT. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FULLY RECOVERED AND DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882199 ↗
• MalfunctionFeb 16, 2021Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT DIFFICULTY TO LOAD WIRE AND OBSTRUCTION WITHIN DEVICE WERE ENCOUNTERED. THE 70% STENOSED TARGET LESION WAS LOCATED IN A CALCIFIED VESSEL. A 3.50MM X 20MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE BUT THERE SEEMED TO BE SOMETHING BLOCKING THE LUMEN ON THE TIP OF THE BALLOON AND WAS UNABLE TO PUT THE BALLOON ONTO THE WIRE AT ALL. THE DEVICE WAS NEVER ENTERED INTO THE PATIENT'S BODY. HOWEVER, DEVICE ANALYSIS REVEALED A TIP DETACHMENT/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334436 ↗
• DeathAug 5, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT BALLOON REMOVAL DIFFICULTIES WERE ENCOUNTERED AND THE PATIENT DIED. THE TARGET LESION WAS LOCATED IN THE VEIN GRAFT TO OBTUSE MARGINAL ARTERY. AFTER A STENT WAS DEPLOYED, A 3.50MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. THE BALLOON WAS INFLATED TO HIGH PRESSURE AND AFTER DEFLATION, THE BALLOON COULD NOT BE EASILY RETRACTED BUT WITH GUIDING CATHETER REPOSITIONING AND BACK TENSION, THE BALLOON DELIVERY CATHETER WAS ABLE TO REMOVED; HOWEVER, THE BALLOON ITSELF WAS RETAINED WITHIN SAPHENOUS VEIN GRAFT (SVG). WIRE POSITION WAS ALSO LOST AND RESEATING OF THE GUIDE AND ANGIOGRAPHY DEMONSTRATED RUPTURE OF THE SVG WITHIN THE STENTED PORTION. A DIFFERENT MANUFACTURES GUIDE WIRE WAS REINTRODUCED INTO THE VESSEL BUT COULD NOT BE PASSED BEYOND THE PREVIOUSLY PLACED STENT. A NEW 3.5X20MM EMERGE BALLOON CATHETER WAS INTRODUCED INTO THE PROXIMAL VEIN GRAFT TO TAMPONADE THE BLEED AND HEPARIN WAS REVERSED WITH PROTAMINE. AFTER A DIFFERENT MANUFACTURERS 0.014 X 180CM GUIDE WIRE WAS USED TO CROSS THE LESION, A 3.5MM X20MM EMERGE BALLOON CATHETER WAS ADVANCED AND INFLATED AT 20 ATMOSPHERES. THE BALLOON WAS LEFT INFLATED WHILE THE PATIENT UNDERWENT CARDIOPU

  Patient problems: Death; Device Embedded In Tissue or Plaque

  MAUDE report 10368442 ↗
• MalfunctionAug 14, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25-JUL-2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. DURING PREPARATION OF A 3.50MM X 20MM NC EMERGE BALLOON CATHETER, IT WAS NOTED THAT THE DEVICE WAS KINKED IN THE PACKAGE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/ SEPARATED.

  Patient problems: No Patient Involvement

  MAUDE report 8894197 ↗
• MalfunctionMay 1, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08-APR-2019. IT WAS REPORTED THAT DIFFICULTY TO LOAD WIRE WAS ENCOUNTERED. A 3.50MM X 20MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR TREATMENT. HOWEVER, A RESISTANCE WAS NOTED DURING INSERTION OF THE GUIDEWIRE INTO THE BALLOON. THEY TOOK THE GUIDEWIRE OUT AND TRIED TO PUT THE PACKAGING MANDREL BACK INTO THE WIRE LUMEN, BUT IT WAS NOT ABLE TO PASS. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HOLE IN THE GUIDEWIRE LUMEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8570217 ↗
• MalfunctionDec 13, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2018. IT WAS REPORTED THAT WIRE LOADING DIFFICULTY WAS ENCOUNTERED. A 3.50MM X 20MM NC EMERGE BALLOON CATHETER WAS USED BUT FAILED TO LOAD OVER THE 0.14 GUIDE WIRE AS EXPECTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HOLE IN WIRE LUMEN. RETURNED PRODUCT CONSISTED OF A NC EMERGE BALLOON CATHETER. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED NO DAMAGES. MICROSCOPIC EXAMINATION REVEALED BUCKLING AND A HOLE ON THE GUIDEWIRE LUMEN 4.7CM FROM THE TIP. THE HOLE IN THE GUIDEWIRE LUMEN IS CONSISTENT WITH A GUIDEWIRE PUNCTURING IT. THE BALLOON IS LOOSELY FOLDED. THE GUIDE WIRE USED IN THE CLINICAL PROCEDURE WAS NOT RETURNED WITH THE DEVICE SO A TEST GUIDE WIRE WAS USED FOR FUNCTIONAL TESTING. PER PRODUCT SPECIFICATION TEST, A .014" TEST GUIDE WIRE WAS ADVANCED INTO THE GUIDE WIRE LUMEN AND WAS UNABLE TO PASS THE BUCKLED SECTION. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8162754 ↗