NC Emerge® H7493926715320Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729846536), received between Aug 13, 2019 and Nov 23, 2023 — classified as 5 malfunctions.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 3.25MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING SECOND INFLATION AT 19 OR 20 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH A NON BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18200070 ↗
• MalfunctionJan 20, 2022Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  DEPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30-DEC-2021. IT WAS REPORTED THAT SHAFT KINK AND ADVANCING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.25MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INSERTION, THE PHYSICIAN NOTED THAT THE SHAFT WAS BREAKING WITH EVEN GENTLE FLEXION APPLIED AND WAS BREAKING IN MANY PLACES. THE BALLOON FAILED TO ADVANCE AS IT WAS BENDING IN MULTIPLE PLACES ALONG THE SHAFT. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13311399 ↗
• MalfunctionJan 6, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.25MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON WIRE WAS SNAPPED IN HALF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13178876 ↗
• MalfunctionMar 4, 2021Break; Break

  IT WAS REPORTED, THAT SHAFT BREAK OCCURRED. THE 80-90% STENOSED, TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED MIDDLE OF RIGHT CORONARY ARTERY. A 3.25MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTICED, THAT THE DELIVERY SHAFT WAS FRACTURED. THE DEVICE WAS COMPLETELY REMOVED WITHOUT ANY ISSUE NOTED. AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11409019 ↗
• MalfunctionAug 13, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22-JUL-2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 3.25MM X 15MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE BALLOON WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8887416 ↗