NC Emerge® H7493926720200Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729846611), received between Oct 13, 2021 and Jan 22, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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.

• MalfunctionJan 22, 2026Nonstandard Device; Material Separation

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. A 2.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE BALLOON COMPONENT SEPARATED FROM THE SHAFT. THE DEVICE WAS SUCCESSFULLY REMOVED, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146706 ↗
• MalfunctionApr 18, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT SLOW DEFLATION OCCURRED. A 2.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON DEFLATED SLOWLY. THE DEVICE WAS REPLACED AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19137661 ↗
• MalfunctionApr 16, 2024Deflation Problem; Adverse Event Without Identified Device or Use Problem; Deflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SLOW BALLOON DEFLATION OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE PHYSICIAN NOTED THAT THE BALLOON DEFLATED SLOWLY. A NEW DEVICE WAS ADVANCED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122253 ↗
• MalfunctionMar 2, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED WHEN IT WAS BEING INFLATED MULTIPLE TIMES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653891 ↗
• MalfunctionOct 13, 2021Material Rupture; Material Rupture

  IT WAS REPORTED VIA USER MEDWATCH MW5104199 THAT BALLOON RUPTURE OCCURRED. A 2.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS WITHDRAWN THROUGH THE CATHETER INTACT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12626664 ↗