Emerge™ H7493918915270Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729806226), received between Jul 9, 2020 and Aug 6, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION ISSUES WERE ENCOUNTERED. A 2.75MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DEFLATION ISSUES WERE ENCOUNTERED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10373186 ↗
• MalfunctionJul 9, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75MM X 15MM EMERGE BALLOON CATHETER WAS USED FOR TREATMENT. DURING AN ATTEMPTED ANGIOPLASTY, THE PHYSICIAN LOADED DEVICE ON WIRE AND ADVANCED THOURGH THE GUIDE TO TREAT THE VESSEL. ABOUT HALFWAY THROUGH THE GUIDE WAS ADVANCED, THE CATHETER SNAPPED INTO TWO. NO FURTHER INFORMATION WAS REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE BROKE JUST OUTSIDE THE GUIDE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER EMERGE BALLOON CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10254882 ↗