NC Emerge® H7493926715550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729846598), received between Sep 30, 2024 and Oct 30, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTIES AND A SHAFT BREAK WERE ENCOUNTERED. THE PATIENT EXPERIENCING CARDIOVASCULAR INSTABILITY AND PERSISTENT ISCHEMIC SYMPTOMS, INCLUDING CHEST PAINS. AN ELECTROCARDIOGRAM (EKG) INDICATED A CONCERN FOR AN INFERIOR ST ELEVATION MYOCARDIAL INFARCTION (STEMI). A 5.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INTERVENTION, THERE WAS DIFFICULTY WITHDRAWING THE BALLOON, WHICH ULTIMATELY RESULTED IN A BALLOON SHAFT FRACTURE. THE BALLOON TIP AND SHAFT REMAINED JUST PROXIMAL TO THE GUIDELINER. WHEN PULLED BACK INTO THE GUIDELINER, ABOUT 20CM OF THE BALLOON REMAINED IN THE PATIENT OUT THE GUIDE. THE BALLOON SHAFT AND TIP WERE SUCCESSFULLY RETRIEVED. ALL EQUIPMENT WAS REMOVED INTACT, WITH NO APPARENT HARM TO THE PATIENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS MODERATELY TORTUOUS WITH 70% STENOSIS AND SNARING WAS PERFORMED TO COMPLETELY REMOVED THE FRACTURED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568310 ↗
• InjurySep 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON TIP DETACHMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 5.50 MM X 15 MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON TIP DETACHED FROM THE BALLOON SHAFT. THE DEVICE WAS REMOVED WITH A SNARE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 5.5 MM NC EMERGE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334468 ↗