Emerge™ H7493918912350Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729806141), received between Mar 19, 2019 and Jul 8, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT FAILURE TO DEFLATE OCCURRED. A 3.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, AFTER THE BALLOON WAS INFLATED, NORMAL DEFLATED DID NOT OCCUR. MANUAL DEFLATION WITH SYRINGE WAS MADE AND THE BALLOON, GUIDE, AND WIRE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690785 ↗
• MalfunctionApr 5, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT BROKE. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615246 ↗
• MalfunctionJun 13, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS USED DURING A BIFURCATION STENTING. HOWEVER, THE OPERATOR KINKED THE CATHETER AND WHEN THE DEVICE WAS RE-INSERTED INTO THE TOUHY, THE SHAFT FRACTURED. A 3.50MM X 12MM EMERGE WAS ALSO USED AT SOME POINT DURING THE PROCEDURE. HOWEVER, IT WAS ALSO NOTED THAT THE CATHETER GOT FRACTURED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8698017 ↗
• MalfunctionMar 19, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50MM X 12MM EMERGE BALLOON WAS SELECTED FOR USE TO DILATE THE LESION. HOWEVER, IT WAS NOTED THAT THE SHAFT OF THE BALLOON BROKE OFF. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434359 ↗