NC Emerge® H7493926708400Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729846307), received between Nov 20, 2018 and Jul 24, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 12 most recent of 12 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 22591519 ↗
• MalfunctionMar 25, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. A 4.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, WHILE PUSHING THE BALLOON DOWN THE SHAFT OF THE CATHETER, THE SHAFT BROKE IN HALF. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS OR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691729 ↗
• MalfunctionJan 17, 2024

  ELDERLY MALE WITH HISTORY OF CORONARY ARTERY DISEASE. PROCEDURE: DIAGNOSTIC LEFT HEART CATHETERIZATION AND PERCUTANEOUS INTERVENTION. THE BALLOON SHAFT BROKE PRIOR TO PACING ON THE WIRE. DEVICE REMOVED WITHOUT KNOWN HARM TO PATIENT AND NEW ONE USED WITHOUT ISSUES. 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 18524804 ↗
• MalfunctionJan 16, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING PREPARATION, A 4.00MM X 8MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. THE BALLOON WAS REMOVED FROM THE HOOP AND WAS PREPPED APPROPRIATELY. PRIOR TO LOADING THE BALLOON INTO THE WIRE, IT WAS NOTICED THAT THE MID SHAFT OF THE BALLOON SNAPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 4.00MM X 8MM NC BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519716 ↗
• MalfunctionNov 25, 2022Break; Break

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. A 4.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION OF THE DEVICE, THE SHAFT FRACTURED IN HALF ABOUT 18 INCHES FROM THE INFLATION PORT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15866691 ↗
• MalfunctionApr 29, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND MODERATELY CALCIFIED MID LEFT MAIN AND LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 4.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION, HOWEVER, DURING THE PROCEDURE THE SHAFT KINKED AND WHEN THE DEVICE WAS REMOVED, A FRACTURE WAS NOTED 10CM INTO THE BALLOON. ANOTHER NC EMERGE BALLOON WAS USED. A 8 X 4.00 PROMUS ELITE MR DRUG-ELUTING STENT WAS THEN INTRODUCED, BUT IT BECAME STUCK IN THE GUIDE CATHETER. WHEN THE DEVICE WAS PULLED BACK, THE STENT WAS NOTED TO BE FRAYED. ALL DEVICES WERE REMOVED FROM THE BODY AND THE PROCEDURE COMPLETED WITH ANOTHER OF THE SAME STENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14255062 ↗
• InjuryJan 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA FACILITY MEDWATCH# (B)(4) THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT RADIAL ARTERY. A 4.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, AFTER THE BALLOON WAS INFLATED WITH HIGH PRESSURE, THE TIP OF THE BALLOON BROKE OFF IN THE RIGHT RADIAL ARTERY. THE PATIENT HAD TO GO TO THE OPERATING ROOM FOR AN OPEN PROCEDURE TO REMOVE THE BROKEN PIECE OF BALLOON. THE BROKEN TIP WAS FOUND USING FLUOROSCOPY AND WAS EASILY REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13307097 ↗
• MalfunctionJul 14, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE CLOSE MIDDLE SEGMENT OF RIGHT CORONARY ARTERY. FOLLOWING STENT IMPLANTATION, A 4.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE DELIVERY SHAFT WAS FRACTURED. THE DEVICE WAS REMOVED DIRECTLY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170081 ↗
• MalfunctionMar 23, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT INCORRECT SIZE OF DEVICE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, IT WAS NOTICED BY THE PHYSICIAN THAT THE OVERHANG ON THE BALLOON WAS MORE THAN HE WOULD HAVE EXPECTED FOR AN 8MM STENT. IT LOOKED LIKE IT WAS 10-12MM. NEVERTHELESS, THE BALLOON WORKED FINE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9866353 ↗
• MalfunctionFeb 20, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS FIBROTIC PLAQUE WITHIN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST DILATION. HOWEVER, THE BALLOON GOT STUCK ONTO THE WIRE AND WAS NOT ABLE TO BE REMOVED WITHOUT PULLING OUT BOTH DEVICES TOGETHER. AFTER THAT, A NEW 4.00MM X 8MM NC EMERGE BALLOON CATHETER AND A NON-BSC GUIDEWIRE WAS PLACED, BUT AFTER ONE INFLATION BOTH DEVICES GOT STUCK ALSO. AND SO BOTH DEVICES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH A PLACEMENT OF A NEW NON-BSC WIRE INTO THE VESSEL AND IVUS CONFIRMED THAT THE STENT WAS WELL APPOSED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9733595 ↗
• MalfunctionNov 29, 2018Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07-NOV-2018. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION, BUT THE BALLOON DELIVERY SHAFT WAS NOTED TO BE KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE SEPARATION. DEVICE EVALUATED BY MANUFACTURER: THE RETURNED PRODUCT CONSISTED OF A NC EMERGE BALLOON CATHETER IN TWO PIECES. THE BALLOON WAS LOOSELY FOLDED. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE MICROSCOPICALLY EXAMINED. THE HYPOTUBE WAS COMPLETELY SEPARATED 41.3CM FROM THE HUB. THE HYPOTUBE FRACTURE SURFACES WERE OVALED AND TORN, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. THERE ARE NUMEROUS HYPOTUBE AND SHAFT KINKS. THE 3MM OF THE SHAFT IS TORN STARTING AT THE EXIT NOTCH, WHICH IS CONSISTENT WITH DAMAGE SEEN WITH THE USE OF A GUIDEWIRE. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8116983 ↗
• MalfunctionNov 20, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN ARTERY. A 4.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE SHAFT BROKE. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL. 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 THAT THE HYPOTUBE IS SEPARATED 69.4CM FROM THE HUB. THERE ARE MULTIPLE KINKS ALONG THE HYPOTUBE. MICROSCOPIC EXAMINATION REVEALED NO ADDITIONAL DAMAGES. THE BALLOON IS STILL TIGHTLY FOLDED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8092115 ↗