NC Emerge® H7493926720450Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729846703), received between Feb 23, 2021 and Mar 18, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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.

• MalfunctionMar 18, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON BURST. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. A 4.50MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE BALLOON HAD BURST. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631172 ↗
• MalfunctionFeb 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS AN AREA OF IN-STENT RESTENOSIS LESION IN THE RIGHT CORONARY ARTERY. A LASER WAS INITIALLY USED TO MODIFY THE LESION. A 4.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED AND INITIALLY INFLATED AT 16 ATMOSPHERES. HOWEVER, DURING THE SECOND INFLATION AT 10 ATMOSPHERES (ATM) IT RUPTURED. IT WAS REPLACED WITH ANOTHER 4.50MM X 15MM NC EMERGE BUT IT ALSO RUPTURED DURING INITIAL INFLATION AT 14 ATM. SUBSEQUENTLY, A 4.50MM X 20MM NC EMERGE WAS ADVANCED BUT ALSO RUPTURED DURING THE SECOND INFLATION AT 16 ATM. THE DEVICES WERE COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A WOLVERINE CUTTING BALLOON FOLLOWED BY A NON-BSC BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369567 ↗