Emerge™ H7493918912120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729806066), received between Jan 15, 2019 and Apr 5, 2019 — 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.

• MalfunctionApr 5, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL IN THE LEFT VENTRICLE. A 1.20MMX12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE BALLOON WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8486841 ↗
• MalfunctionJan 15, 2019Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18-DEC-2018. IT WAS REPORTED THAT BALLOON INFLATION ISSUES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE PERCUTANEOUS CORONARY INTERVENTION (PCI). A 1.20MM X 12MM FG EMERGE CATHETER WAS USED WAS ADVANCE FOR DILATION. HOWEVER, DEFLATION DIFFICULTIES OCCURED THE BALLOON COULDN'T DILATE SUFFICIENTLY. THE PROCEDURE WAS CONTINUED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8247734 ↗