NC Emerge® H7493926708500Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729846321), received between Jan 29, 2019 and Mar 25, 2025 — classified as 1 death, 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• DeathMar 25, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT WAS PRESENTED WITH COMPLAINTS OF CHEST PAIN. AN ELECTROCARDIOGRAM (ECG) REVEALED DIFFUSE ST-SEGMENT DEPRESSIONS ALONG WITH ST ELEVATIONS IN THE AVR LEAD AND A LARGE MYOCARDIAL INFARCTION (MI WAS DIAGNOSED. THE PATIENT WAS IMMEDIATELY TRANSFERRED TO THE CATHETERIZATION ROOM FOR FURTHER EVALUATION AND TREATMENT. DURING CORONARY ANGIOGRAPHY, SIGNIFICANT STENOSIS OF THE LEFT MAIN ARTERY (LM) WAS IDENTIFIED, ACCOMPANIED BY HEAVY CALCIFICATION IN THE DISTAL SEGMENT OF THE ARTERY, WHICH COMPLICATED THE INTERVENTION. WIRES WERE ADVANCED INTO THE LEFT ANTERIOR DESCENDING (LAD) AND LEFT CIRCUMFLEX (LCX) ARTERIES TO FACILITATE TREATMENT. FOLLOWING THIS, BALLOON DILATION WAS PERFORMED USING A 2.5 NC EMERGE BALLOON CATHETER TO OPEN THE NARROWED ARTERIES, AFTER WHICH A 4.5 X 15 NON-BOSTON SCIENTIFIC STENT WAS IMPLANTED. HOWEVER, FURTHER DILATION WITH A 5.00MM X 8MM NC EMERGE BALLOON WAS NECESSARY TO EXPAND THE STENT IN A CALCIFIED AREA THAT DID NOT OPEN PROPERLY. FOLLOWING DILATATION, A SIGNIFICANT PERFORATION OF THE ARTERY OCCURRED, LEADING TO BLOOD EXTRAVASATION INTO THE PERICARDIUM. THIS RESULTED IN AN ACUTE DETERIORATION OF THE PATIENT'S CON

  Patient problems: Loss of consciousness; Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 21690288 ↗
• InjuryMay 16, 2023Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT WAS BEING TREATED FOR BIFURCATION LESION AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS CIRCUMFLEX ARTERY AND RAMUS CORONARY ARTERY. AFTER PLACING STENTS AT THE BIFURCATION, A 5.00MM X 8MM NC EMERGE BALLOON CATHETER WAS USED TO PERFORM THE BALLOON KISSING TECHNIQUE. HOWEVER, WHEN TRYING TO WITHDRAW THE BALLOON FROM THE RAMUS, THE BALLOON ADHERED AND BECAME STUCK TO THE STENT STRUT AND APPROXIMATELY 12-18 INCHES OF THE BALLOON SHAFT WERE LEFT INSIDE THE PATIENT. AFTER SEVERAL HOURS, THE BALLOON WAS EXTRACTED AFTER MULTIPLE ATTEMPTS AT SNARES. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16939381 ↗
• InjuryAug 16, 2021Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 5.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING REMOVAL, THE BALLOON COULD NOT GET BACK INTO THE GUIDE AND THE SHAFT BROKE. THE DEVICE WAS REMOVED USING A TRAPPER DEVICE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12325246 ↗
• MalfunctionApr 26, 2021Deflation Problem; Entrapment of Device; Difficult to Remove; Material Integrity Problem; Deflation Problem; Entrapment of Device; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT CATHETER ENTRAPMENT AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED LEFT MAIN AND PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN IMPLANTED A 4.0MM STENT AND A 5.00MM X 8MM NC EMERGE BALLOON CATHETER WAS USED FOR POST-DILATATION. HOWEVER, DURING DEFLATION OF BALLOON, RESISTANCE WAS FELT IN REMOVING THE BALLOON FROM THE STENT AND MULITPLE ATTEMPTS WERE MADE TO DEFLATE THE BALLOON TO ITS SMALLEST PROFILE. THE TIP AND PROXIMAL OF THE BALLOON WAS KINKED AND THE BALLOON BECAME STUCK ON THE GUIDEWIRE. AFTER FULL DEFLATION, THE PHYSICIAN PULLED THE BALLOON VERY HARD AND THE BALLOON WAS REMOVED FROM THE LEFT MAIN STENT. THE BALLOON AND GUIDEWIRE WERE REMOVED TOGETHER INTACT AND THE BALLOON CATHETER WAS NOTED TO BE SHORTENED OR WRINKLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11725287 ↗
• MalfunctionAug 25, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 5.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING PROCEDURE, THE DEVICE DELIVERY SHAFT WAS FRACTURED. THE DEVICE WAS COMPLETELY REMOVED BY SIMPLY PULLING IT OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10449420 ↗
• MalfunctionOct 22, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT INCORRECT LABELING OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN ARTERY. A 5.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION UNDER RADIOGRAPHY, IT WAS NOTED THAT THE SIZE OF THE DEVICE WAS MORE THAN WHAT THE PACKAGE LABEL INDICATED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9222003 ↗
• MalfunctionSep 30, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SHAFT PERFORATION OCCURRED. A 5.00MM X 8MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE CHOICE PT EXTRA SUPPORT WIRE CAME OUT THE END OF BALLOON INSTEAD OF THE RX PORT. THE BALLOON NEVER ENTERED THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER NC EMERGE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9136218 ↗
• MalfunctionJan 29, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURED. THE TARGET LESION WAS LOCATED IN THE VERY TORTUOUS CIRCUMFLEX. A 5.00MM X 8MM EMERGE MR BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTICED THAT THE PROXIMAL SHAFT SPLIT 15 INCHES FROM THE HUB. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8286951 ↗