Emerge™ H7493918920220Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729806318), received between Sep 26, 2019 and May 19, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.25MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848376 ↗
• MalfunctionDec 2, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE GREATER THAN 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED DIAGONAL CORONARY ARTERY. A 2.25MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE MID SHAFT OF THE BALLOON CATHETER FRACTURED AND BROKE IN HALF. THE DEVICE WAS REMOVED BY SIMPLY PULLING OUT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10936923 ↗
• MalfunctionMar 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9777730 ↗
• MalfunctionNov 7, 2019Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. DURING PREPARATION IT WAS NOTED THAT THE 2.25MM X 20MM EMERGE CATHETER WAS BROKEN IN HALF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9292819 ↗
• MalfunctionOct 24, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.25MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF REPORTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9233673 ↗
• MalfunctionSep 26, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A HIGHLY CALCIFIED AND TORTUOUS ARTERY. A 2.25MM X 20MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, WHEN TRIED TO CROSS THE LESION, IT WAS NOTED THAT THE HYPOTUBE WAS BENT WITH FORCE AND THE SHAFT BROKE. THE BREAK WAS OUTSIDE THE PATIENT'S BODY. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9124991 ↗