Emerge™ H7493918930200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729806394), received between Jun 9, 2021 and Jan 7, 2026 — classified as 1 injury, 2 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.

• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.00MM X 20MM EMERGE? AND 2.00MM X 30MM EMERGE? BALLOON CATHETER WERE ADVANCED FOR USED. HOWEVER, DURING THE PROCEDURE, A DISTAL DISSECTION WAS OBSERVED. A STENT WAS PLACED AND THE EVENT RESOLVED WITHOUT SEQUELAE.

  Patient problems: Vascular Dissection

  MAUDE report 23999649 ↗
• MalfunctionApr 1, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. TWO 2.00MM X 30MM EMERGE BALLOON CATHETER WAS PREPARED, HOWEVER, BOTH OF THE DISTAL SHAFT BREAK. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13979740 ↗
• MalfunctionJun 9, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 30MM EMERGE BALLOON CATHETER WAS INTRODUCED FOR DILATATION. HOWEVER, AS THE DEVICE WAS BEING ADVANCED INTO THE LESION, THE SHAFT BROKE OUTSIDE THE PATIENT AT APPROXIMATELY 6 INCHES FROM THE HUB. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11966595 ↗