NC Emerge® H7493926715220Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729846499), received between Sep 4, 2018 and Sep 6, 2024 — classified as 3 injuries, 4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2024Break; Difficult to Remove; Failure to Advance; Break; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK, DIFFICULT REMOVAL AND UNRETRIEVED DEVICE FRAGMENT OCCURRED RESULTING IN PATIENT COMPLICATIONS. THE 85% OCCLUDED, STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED MID-CIRCUMFLEX (CX) ARTERY. A 2.25 MM X 15 MM NC EMERGE BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS REPEATEDLY ATTEMPTED TO CROSS BUT FAILED AGAIN. UPON ATTEMPTED REMOVAL, THE DEVICE WAS STUCK IN THE LESION, AND THE DISTAL SHAFT WAS FRACTURED. THE FRACTURE EXTENDED APPROXIMATELY 35 CM FROM THE MID-CX THROUGH THE LEFT MAIN (LM) ARTERY AND INTO THE ASCENDING AORTA, AND WAS UNRETRIEVED FROM THE PATIENT. SUBSEQUENTLY, THE PATIENT EXPERIENCED ARRHYTHMIA, MYOCARDIAL INFARCTION/ISCHEMIA, ST SEGMENT ELEVATION, THROMBOSIS, AND VESSEL OCCLUSION. THE PROCEDURE WAS CANCELLED. NO FURTHER DETAILS WERE REPORTED.

  Patient problems: Arrhythmia; Foreign Body In Patient; Myocardial Infarction; Non specific EKG/ECG Changes; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 20158831 ↗
• MalfunctionAug 20, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON CATHETER BECAME STUCK ON THE GUIDEWIRE. A 2.25MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON ADHERED TO THE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20006001 ↗
• MalfunctionMay 8, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 2.25MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, UPON REMOVING THE BALLOON FROM THE GUIDE, THE MIDSHAFT OF THE BALLOON BROKE IN HALF. THE DETACHED PORTION OF THE DEVICE WAS PULLED OUT OF THE NON-BOSTON SCIENTIFIC GUIDE CATHETER AND BODY, AND THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19269785 ↗
• MalfunctionApr 17, 2022Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05-APR-2022. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. A 2.25MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON FAILED TO INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14132244 ↗
• MalfunctionMay 18, 2021Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT A PACKAGING ISSUE OCCURRED. WHEN THE BOX FOR A 2.25MM X 15MM NC EMERGE BALLOON CATHETER, THE LOT NUMBER FOR THE DEVICE INSIDE THE BOX WAS DIFFERENT THAN THE LOT NUMBER ON THE BOX. THE BOX TAB WAS NOT LOOSE PRIOR TO OPENING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845442 ↗
• InjuryOct 24, 2019Material 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 BALLOON RUPTURE AND BALLOON DETACHMENT OCCURRED. AFTER A NON-BSC WIRE PASSED THROUGH THE LESION, A 2.25MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED AND GOT SEPARATED. THE PATIENT WAS LEFT LAB ON EXTRACORPOREAL MEMBRANE OXYGENATION AND WAS SENT TO CORONARY CARE UNIT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 9235053 ↗
• InjurySep 4, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.25MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS NOTED TO HAVE A BEND ON THE SHAFT. HOWEVER, THE PHYSICIAN DECIDED IT WAS FINE TO USE. AS THE DEVICE WAS ADVANCED, THE BALLOON STOPPED, BUT THE SHAFT AND HUB WAS ALL THE WAY TO THE HEMOSTASIS VALVE AND WAS BROKEN IN TWO AT THE POINT OF THE TRANSITION TO THE FLEXIBLE PART OF THE SHAFT. A GUIDEZILLA II WAS ADVANCED OVER THE WIRE AND ATTEMPTED TO GRAB THE BROKEN PORTION THAT REMAINED IN THE LAD. IT THEN WENT FURTHER DOWN THE VESSEL. A SNARE WAS ATTEMPTED, BUT DID NOT WORK EITHER. A TRAPPER BALLOON WAS THEN USED TO TRAP THE BALLOON IN THE GUIDE AND EVERYTHING WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7843296 ↗