Emerge™ H7493919108150Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729807100), received between Jun 4, 2019 and Aug 20, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

• MalfunctionAug 20, 2026Fluid/Blood Leak; Material Rupture

  It was reported that balloon rupture occurred.The 82% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery. A 1.50mm X 8mm Emerge? balloon catheter was prepared for dilatation. However, due to poor sealing the balloon has ruptured and observed a water leaking. The procedure was completed with another of the same device. There were no patient complications, and the patient condition is stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50360113 ↗
• MalfunctionFeb 10, 2026Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 92% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 1.50MM X 8MM EMERGE? BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PREPARATION, IT WAS NOTED THAT THE BALLOON WAS RUPTURED AND LEAKING LIQUID. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304764 ↗
• MalfunctionJan 29, 2026Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE DIFFUSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON CATHETER WAS STUCK AND COULD NOT BE WITHDRAWN. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24214361 ↗
• MalfunctionJan 12, 2025Inflation Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19-DEC-2024. IT WAS REPORTED THAT INFLATION FAILURE WAS ENCOUNTERED. A 1.50MM X 8MM EMERGE BALLOON CATHETER WAS USED DURING THE MARSHALL PROCEDURE FOR ATRIAL FIBRILLATION. HOWEVER, THE BALLOON COULD NOT BE OPENED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A PINHOLE IN THE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21133769 ↗
• MalfunctionJun 4, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED. THE TARGET LESION WAS LOCATED IN THE FRONT DESCENDING BRANCH ARTERY. A 1.50MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, SIGNIFICANT RESISTANCE WERE ENCOUNTERED WITH THE NON BSC GUIDEWIRE. BOTH DEVICE WERE REMOVED TOGETHER FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8666178 ↗