Emerge™ H7493919112200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729806691), received between Apr 27, 2022 and May 16, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT THE BALLOON CATHETER BECAME STUCK, AND REMOVAL DIFFICULTIES OCCURRED. THE PATIENT HAD SUSPECTED HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY AND UNDERWENT A CHEMICAL ABLATION OF THE CORONARY SINUS. A 2.00MM X 12MM EMERGE BALLOON CATHETER BECAME STUCK IN THE LESION DURING THE PROCEDURE AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE DEVICE WAS DAMAGED DURING THE CHEMICAL ABLATION PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS IN STABLE CONDITION FOLLOWING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040441 ↗
• MalfunctionNov 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION BELOW REACHING THE NOMINAL PRESSURE, THE BALLOON RUPTURED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15845737 ↗
• MalfunctionApr 27, 2022Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04-APR-2022. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 95% STENOSED, 10X2.00MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE DELIVERY SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED MARKERBAND DAMAGE. RETURNED PRODUCT CONSISTED OF AN EMERGE OTW BALLOON CATHETER. THE DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED. AT 96.8CM, AND 98.4CM FROM THE STRAIN RELIEF OF THE DEVICE, THE SHAFT WAS KINKED. AT 4MM FROM THE TIP OF THE DEVICE, FOR A LENGTH OF 12MM, THE GUIDEWIRE LUMEN AND DISTAL MARKERBAND WERE FLATTENED. THE FOLDS OF THE BALLOON WERE TIGHT HOWEVER, THEY WERE MANIPULATED OPEN BUT HAVE NO SIGNS OF INFLATION. PRODUCT ANALYSIS CONFIRMED THE REPORTED EVENT, AS THE SHAFT OF THE DEVICE WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14226814 ↗