NC Emerge® H7493926708250Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729846246), received between Sep 14, 2020 and Mar 3, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, RESISTANCE WAS ENCOUNTERED AS THE DEVICE WAS ADVANCED THROUGH THE LESION. WHILE TRYING TO PUSH THE DEVICE, THE SHAFT BROKE IN HALF. THE DISTAL PORTION OF THE SHAFT THAT REMAINED ON THE GUIDEWIRE WAS BEING CAPTURED BY THE GUIDE CATHETER. EVERYTHING WAS REMOVED SUCCESSFULLY, AND NEW EQUIPMENT WAS THEN USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED, AND NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21504422 ↗
• MalfunctionFeb 1, 2024Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 2.50MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING INSERTION OF THE BALLOON CATHETER THROUGH THE HEMOSTASIS VALVE, THE BALLOON HUB WAS NOTED TO BE BENT AND FRACTURED. THE TECHNICIAN TRIED THE BEND THE HUB BACK; HOWEVER, IT SNAPPED OFF THE CATHETER RIGHT AT THE HUB. THE DEVICE WAS REMOVED FROM THE HEMOSTASIS VALVE WITH NO OTHER ISSUES. A 2.5 X 8 EMERGE BALLOON CATHETER WAS USED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18627505 ↗
• MalfunctionAug 8, 2022Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT TIP DAMAGE OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. A 2.50MM X 8MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION. HOWEVER, DURING PREPARATION, THE CATHETER TIP WAS BENT AND DAMAGED. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER; RETURNED DEVICE ANALYSIS REVEALED SHAFT BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15186271 ↗
• MalfunctionSep 13, 2021Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01SEP2021. IT WAS REPORTED THAT SHAFT BREAK NEAR THE HUB OCCURRED. DURING THE INTRODUCTION OF A 2.50MM X 8MM NC EMERGE BALLOON CATHETER, THE SHAFT BROKE OFF NEAR THE HUB. THE DETACHED PORTION WAS PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SHAFT BREAK 19CM FROM THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12463348 ↗
• MalfunctionSep 14, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 8MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, BEFORE THE DEVICE WAS PUT INTO THE BODY, IT WAS NOTED THAT THE SHAFT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10533028 ↗