NC Emerge® H7493926712550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729846468), received between Mar 17, 2023 and Sep 17, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Break

  It was reported via MedWatch report 2000330000-2026-8055 that shaft break occurred, requiring additional intervention.The intended procedure included right femoral sheath side-port angiography and left heart catheterization. A complex percutaneous coronary intervention of the left main was performed involving multiple pieces of equipment. Following final post-dilatation, it was believed that the wire was unraveled and wrapped around the 5.50mm x 12mm NC Emerge balloon. The balloon catheter shaft broke at the monorail opening. The devices were recovered using a snare from the left radial access. The patient was unharmed and stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808412 ↗
• MalfunctionMar 17, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 5.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, DURING ADVANCING ACROSS THE LESION, THE SHAFT BROKE INSIDE THE SHEATH. THE DEVICE WAS PULLED OUT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER NC EMERGE BALLOON. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566110 ↗