Emerge™ H7493919112150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729806684), received between Apr 27, 2022 and Aug 5, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination” (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 16, 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.

• MalfunctionAug 5, 2024Contamination; Packaging Problem; Contamination; Packaging Problem

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 1.50MM X 12MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS FOUND THAT THE INNER PACKAGING WAS DAMAGED, AND THE DEVICE STERILITY WAS COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19910949 ↗
• MalfunctionNov 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. A 1.50MM X 12MM EMERGE OTW BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT INJURIES REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE 20% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS MARSHALL VEIN. THE BALLOON WAS RUPTURED DURING THE SECOND INFLATION AT 8 ATMOSPHERES FOR 15 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093143 ↗
• MalfunctionApr 27, 2022Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. A 1.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, BALLOON LEAKAGE WAS NOTED. 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 BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14229084 ↗