NC Emerge® H7493926712400Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729846437), received between Sep 15, 2021 and Jul 24, 2025 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Oct 24, 2019Class IITerminated

   Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.

   Z-0579-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE OVER 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND HEAVILY CALCIFIED CORONARY ARTERY. A 4.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 13 ATMOSPHERES (ATM) FOR LESS THAN 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND A 4.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED, BUT IT ALSO RUPTURED DURING INITIAL INFLATION AT 12 ATM FOR LESS THAN 30 SECONDS. SUBSEQUENTLY, ANOTHER 4.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED, BUT IT ALSO RUPTURED DURING INITIAL INFLATION AT 13 ATM FOR LESS THAN 30 SECONDS. THE DEVICE WAS THEN REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22591510 ↗
• MalfunctionJul 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE OVER 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND HEAVILY CALCIFIED CORONARY ARTERY. A 4.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 13 ATMOSPHERES (ATM) FOR LESS THAN 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND A 4.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED, BUT IT ALSO RUPTURED DURING INITIAL INFLATION AT 12 ATM FOR LESS THAN 30 SECONDS. SUBSEQUENTLY, ANOTHER 4.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED, BUT IT ALSO RUPTURED DURING INITIAL INFLATION AT 13 ATM FOR LESS THAN 30 SECONDS. THE DEVICE WAS THEN REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22591478 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL PERFORATION AND PERICARDIAL EFFUSION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER A 1.5 ROTA BURR AND A 3.5 NC EMERGE BALLOON CATHETER WERE USED TO MODIFY THE TARGET LESION, A 4.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, DURING INFLATION, THE BALLOON CAUSED CALCIUM TO SHIFT, LEADING TO VESSEL PERFORATION AND PERICARDIAL EFFUSION. TAMPONADE WITH BALLOON INFLATION AND PLACEMENT OF A COVERED STENT WERE PERFORMED TO TREAT THE PERFORATION. A PERICARDIAL TAP AND DRAINAGE WERE ALSO PERFORMED TO MANAGE THE EFFUSION, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS STABLE AND WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 22198931 ↗
• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORETD THAT SHAFT BREAK OCCURRED. A 4.00MM X 12MM NC EMERGE WAS ADVANCED FOR DILATION. HOWEVER, A SHAFT BREAK OCCURRED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21310730 ↗
• InjuryDec 10, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT BALLOON DEFLATION FAILURE OCCURRED. A 4.00 MM X 12 MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON FAILED TO DEFLATE, LEADING TO PROLONGED BALLOON INFLATION AND WHAT WAS LIKELY A LEFT MAIN OCCLUSION DURING THE PROCEDURE. THIS RESULTED IN CHEST PAIN, ST ELEVATION, AND HYPOTENSION. THE BALLOON WAS ABLE TO BE PUNCTURED AND REMOVED, WHICH ALLEVIATED THE SYMPTOMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Chest Pain; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes; Obstruction/Occlusion

  MAUDE report 20895203 ↗
• MalfunctionNov 26, 2024

  CATH PCI (PERCUTANEOUS CORONARY INTERVENTION)- NC EMERGE 4 MM/12MM BALLOON FAILED TO DEFLATE RESULTING IN PROLONGED BALLOON INFLATION AND "LIKELY LEFT MAIN OCCLUSION" INTRA-PROCEDURE, CAUSING CHEST PAIN, ST ELEVATION, AND HYPOTENSION. RESOLVED AFTER MD PUNCTURED THE BALLOON TO REMOVE IT.

  Patient problems: Chest Pain; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 20782068 ↗
• MalfunctionJun 28, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE. THE STENOSED TARGET LESION WAS LOCATED IN THE MID TO PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 4.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, COMPLICATIONS OCCURRED WHEN THE BALLOON DID NOT MAINTAIN THE INTENDED INFLATION PRESSURE OF 12 ATMOSPHERES, DEFLATING TO 10 ATMOSPHERES INSTEAD. DESPITE ATTEMPTS TO DEFLATE THE BALLOON OVER 30 TO 90 SECONDS, IT REMAINED OVERINFLATED, LEADING TO THE PROCEDURE'S TERMINATION. THE BALLOON'S REMOVAL WAS CHALLENGING, NECESSITATING AN UNCONVENTIONAL METHOD. THE PHYSICIAN DECIDED TO PUNCTURE THE BALLOON WITH A NEEDLE OUTSIDE THE PATIENT'S BODY TO AID ITS RELEASE FROM THE SHEATH AND ENSURE ITS REMOVAL. UNFORTUNATELY, THE PATIENT DEVELOPED ISCHEMIC SYMPTOMS, INCLUDING ST ELEVATION AND CHEST PAIN, DURING THIS PROCESS, WHICH LED TO THE IMMEDIATE CESSATION OF THE PROCEDURE. AFTER THE BALLOON AND RELATED EQUIPMENT WERE REMOVED, THE PATIENT'S CONDITION STABILIZED. DESPITE ENCOUNTERING PROCEDURAL DIFFICULTIES, TIMELY INTERVENTION PREVENTED FURTHER COMPLICATIONS, ENSURING PATIENT SAFETY FOLLOWING THE INCIDENT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Chest Pain; Ischemia; Non specific EKG/ECG Changes

  MAUDE report 19633574 ↗
• MalfunctionNov 1, 2023Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT THE DIFFICULTY ADVANCING OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED VESSEL. TWO 4.00MM X 12MM NC EMERGE WERE SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING PREPARATION, AFTER LOADING THE BALLOON OVER THE WIRE, THE BALLOON WOULD NOT ADVANCE THROUGH THE BOSTON SCIENTIFIC GUIDE CATHETER. THE PHYSICIAN MADE SURE THERE WERE NOT ANY OBSTRUCTIONS, AND THE BALLOON WAS NOT BROKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR IN THE SHAFT OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18052072 ↗
• MalfunctionNov 1, 2023Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT THE DIFFICULTY ADVANCING OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED VESSEL. TWO 4.00MM X 12MM NC EMERGE WERE SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING PREPARATION, AFTER LOADING THE BALLOON OVER THE WIRE, THE BALLOON WOULD NOT ADVANCE THROUGH THE BOSTON SCIENTIFIC GUIDE CATHETER. THE PHYSICIAN MADE SURE THERE WERE NOT ANY OBSTRUCTIONS, AND THE BALLOON WAS NOT BROKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A PINHOLE TO THE BALLOON AT THE DISTAL END OF THE PROXIMAL MARKERBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18052032 ↗
• InjuryMar 16, 2023Material Rupture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Material Rupture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BALLOON RUPTURED, AND BALLOON MATERIAL CAME OFF THE TIP AND EMBOLIZED IN THE DISTAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). A 4.00MM X 12MM NC EMERGE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 16 ATMOSPHERES AND APPEARED TO RUPTURE CIRCUMFERENTIALLY, AND THE TIP SEEMED TO COME OFF AND GO DOWN THE RCA. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO REMOVE THE DEVICE FRAGMENT, THE PATIENT WAS SENT TO CORONARY ARTERY BYPASS (CABG) SURGERY. THE DEVICE FRAGMENTS REMAIN IN THE RCA. THE PATIENT WAS DISCHARGED IN GOOD CONDITION POST-SURGERY. IT WAS FURTHER REPORTED THAT THIS ISSUE WAS REPORTED VIA USER FACILITY MAUDE#: MW5115465.

  Patient problems: Foreign Body In Patient

  MAUDE report 16555077 ↗
• MalfunctionSep 15, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 4.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, THE MID SHAFT BROKE WHEN ADVANCED INTO THE CALCIFIED LESION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 4.0X8MM NC EMERGE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12477677 ↗