Emerge™ H7493919115150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729806790), received between Oct 28, 2020 and Jan 13, 2025 — 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.

• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED, 3.5MMX20MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 1.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE DELIVERY SHAFT FRACTURED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21144743 ↗
• InjuryJul 13, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED, 1.5MM X 1.5MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. HOWEVER, DURING THE PROCEDURE, THE BALLOON DELIVERY SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15002837 ↗
• MalfunctionOct 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 1.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION UNDER NOMINAL PRESSURE, THE BALLOON RUPTURED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10750325 ↗