NC Emerge® H7493926712370Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729846420), received between Sep 23, 2019 and Jan 4, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT WAS PRESENTED WITH CARDIOVASCULAR ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN MODERATE TO SEVERELY CALCIFIED AND TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD) AS WELL AS RADIAL ARTERY. A 3.75MM X 12MM, 3.75MM X 20MM, 3.75MM X 12MM, AND 3.75MM X 15MM NC EMERGE BALLOON CATHETERS WERE USED. HOWEVER, THE SHAFT OF THE FOUR CATHETERS WERE BADLY BENT AND BROKEN. THE DEVICES WERE BOTH PULLED OUT INTACT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH DIFFERENT BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096552 ↗
• MalfunctionJan 3, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT WAS PRESENTED WITH CARDIOVASCULAR ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN MODERATE TO SEVERELY CALCIFIED AND TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD) AS WELL AS RADIAL ARTERY. A 3.75MM X 12MM, 3.75MM X 20MM, 3.75MM X 12MM, AND 3.75MM X 15MM NC EMERGE BALLOON CATHETERS WERE USED. HOWEVER, THE SHAFT OF THE FOUR CATHETERS WERE BADLY BENT AND BROKEN. THE DEVICES WERE BOTH PULLED OUT INTACT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED DIFFERENT BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16090927 ↗
• MalfunctionDec 13, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.75MM X 12MM NC EMERGE BALLOON CATHETER WAS SELETED FOR USE; HOWEVER, IT WAS NOTED THAT THE BALLOON DELIVERY SHAFT, NEAR THE HUB WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9468127 ↗
• MalfunctionSep 23, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.75MM X 12MM NC EMERGE BALLOON CATHETER AND A 6MMX3.25MM WOLVERINE BALLOON CATHETER WERE SELECTED FOR USE. HOWEVER, DURING PROCEDURE, THE SHAFTS WERE SNAPPED WHEN ATTEMPTED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9106562 ↗