Emerge™ Push H7493919008120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729806042), received between Apr 1, 2019 and Jan 22, 2021 — classified as 3 malfunctions.

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

• MalfunctionJan 22, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A 1.20MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON TWINED WITH THE GUIDEWIRE. THE ENTRAPPED DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11216224 ↗
• MalfunctionSep 23, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 92% STENOSED TARGET LESION WAS LOCATED IN THE MIDDLE AND DISTAL END OF THE LEFT ANTERIOR DESCENDING ARTERY. A 1.20MM X 8MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING ADVANCING FOR THE SECOND TIME, THE MIDDLE OF THE DELIVERY SHAFT WAS FRACTURED (MORE THEN 15 CM FROM THE HUB). THE DEVICE WAS DIRECTLY AND COMPLETELY REMOVED FROM THE PATIENT WITHOUT ANY INTERVENTION AND 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 9106271 ↗
• MalfunctionApr 1, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 1.20MM X 8MM EMERGE PUSH BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHILE THE BALLOON WAS LOADING ONTO THE WIRE THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT SERIOUS INJURY NOR COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8469717 ↗