NC Emerge® H7493926712450Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729846444), received between Dec 30, 2019 and Apr 26, 2024 — classified as 1 injury, 6 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.

• InjuryApr 26, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT VESSEL PERFORATION, SHAFT BREAK AND REMOVAL DIFFICULTY OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER TREATMENT WITH ROTATIONAL ATHERECTOMY AND SHOCKWAVE THERAPY TO ADDRESS THE CALCIFICATION, A STENT WAS IMPLANTED IN THE LAD. A 4.50MM X 12MM NC EMERGE BALLOON CATHETER WAS THEN SELECTED FOR POST DILATION OF THE STENT. DURING POST DILATION, THE VESSEL WAS PERFORATED. THE PATIENT CONDITION DECLINED, AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. UPON REMOVAL OF THE DEFLATED EMERGE BALLOON, THE BALLOON CATHETER BROKE INTO TWO PIECES AND PART OF THE SHAFT REMAINED IN THE PATIENT'S LEFT MAIN ARTERY. AFTER MULTIPLE ATTEMPTS WITH A SNARE, THE BALLOON SHAFT WAS SUCCESSFULLY REMOVED. CPR WAS CONTINUED DURING THE PROCEDURE AND COILS WERE PLACED TO TREAT THE PERFORATION. THE PATIENT WAS INTUBATED AND AT THE TIME OF REPORTING WAS IN THE INTENSIVE CARE UNIT (ICU).

  Patient problems: Perforation of Vessels

  MAUDE report 19197165 ↗
• MalfunctionAug 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. A 4.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 16 ATMOSPHERES, THE BALLOON BURST. THE DEVICE WAS REPLACED WITH ANOTHER 4.50MM X 12MM NC EMERGE BALLOON CATHETER WHICH ALSO RUPTURED AT 16 ATMOSPHERES. THE DEVICE WAS REMOVED SUCCESSFULLY AND THERE WERE NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT. 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 17651909 ↗
• MalfunctionAug 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. A 4.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 16 ATMOSPHERES, THE BALLOON BURST. THE DEVICE WAS REPLACED WITH ANOTHER 4.50MM X 12MM NC EMERGE BALLOON CATHETER WHICH ALSO RUPTURED AT 16 ATMOSPHERES. THE DEVICE WAS REMOVED SUCCESSFULLY AND THERE WERE NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT. 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 17651879 ↗
• MalfunctionAug 31, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED, THE PATIENT PRESENTED WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) AND UNDERWENT LEFT HEART CATHETERIZATION (LHC). THE TARGET LESION WAS LOCATED IN A NON-CALCIFIED VESSEL. A 4.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 14 ATMOSPHERES, THE BALLOON BURST. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331860 ↗
• MalfunctionJul 27, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.50MM X 12MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE MIDDLE PART OF THE SHAFT WAS FRACTURED WHEN THE BALLOON CATHETER WAS REMOVED FROM THE CARRIER TUBE. THE PROCEDURE WAS COMPETED WITH ANOTHER NC EMERGE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS REPORTED VIA MEDWATCH (B)(4) THAT THE LEFT MAIN WIRE WAS FRACTURED FROM THE NC EMERGE BALLOON CATHETER BREAKING IN HALF DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12232308 ↗
• MalfunctionJul 19, 2021Break; Fracture

  PATIENT WITH HISTORY OF HYPERTENSION AND CONGESTIVE HEART FAILURE WAS ADMITTED FOR A DIAGNOSTIC CATHETERIZATION WITH PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOGRAM. THE LEFT MAIN WIRE FRACTURED, FROM THE NC EMERGE® PTCA DILATATION CATHETER, BROKE IN HALF DURING THE PROCEDURE. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND NO KNOWN HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12187757 ↗
• MalfunctionDec 30, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT BALLOON REMOVAL DIFFICULTIES WERE ENCOUNTERED. A 4.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED AND INFLATED. HOWEVER, IT WAS NOTED THAT THERE WAS A SIGNIFICANT AMOUNT OF DIFFICULTY IN REMOVING THE SYSTEM. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS PULLED HARD UNTIL EVERYTHING CAME BACK AND WAS REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9532463 ↗