Emerge™ Push H7493919015120Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729806004), received between Feb 4, 2019 and Feb 4, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 1.20MM X 15MM EMERGE PUSH BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DEVICE BECAME STUCK WITH THE NON-BSC GUIDE WIRE. THE DEVICE COULD NOT BE ADVANCED NOR COULD BE PULLED OUT FROM THE WIRE. BOTH DEVICES WERE REMOVED TOGETHER FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A NEW WIRE AND A NEW BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8302101 ↗