Emerge™ H7493919108250Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729807131), received between Sep 8, 2022 and Sep 18, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Fluid/Blood Leak; Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828663 ↗
• MalfunctionApr 23, 2024Leak/Splash; Difficult to Advance; Leak/Splash; Difficult to Advance

  IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 8MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE, BUT IT COULD NOT REACH THE LESION AND IT WAS NOTED THAT THE BALLOON WAS LEAKING GAS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS LEAKING OUTSIDE THE PATIENTS BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164643 ↗
• MalfunctionSep 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT GAS LEAKAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEPTAL BRANCH VESSEL. A 2.50MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. ONE-THREE (1-3) STANDARD INFLATIONS WERE PERFORMED; HOWEVER THE BALLOON WAS NOT SEALED AS EXPECTED AND WAS LEAKING GAS AFTER BEING PRESSURIZED BY THE PUMP. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17790180 ↗
• MalfunctionSep 8, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT FROZE ON WIRE OCCURRED. THE 24MM X 3.5MM, 90% STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 2.50MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DEVICE WAS ENTRAPPED WITH THE NON-BOSTON SCIENTIFIC GUIDEWIRE AND COULD NOT BE WITHDRAWN. EVENTUALLY, BOTH DEVICES WITHDRAWN TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15379149 ↗