Emerge™ H7493918908120Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729806486), received between Apr 1, 2024 and Feb 11, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH A CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 1.20MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BROKE OFF IN THE CORONARY ARTERY. ANOTHER 1.20MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED; BUT THE BALLOON ALSO BROKE OFF IN THE CORONARY ARTERY. THE DEVICES WERE SIMPLY REMOVED FROM THE PATIENT IN ONE PIECE, AND AN ALTERNATE DEVICE WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314530 ↗
• MalfunctionOct 3, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 1.20MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE MIDDLE OF THE BALLOON WAS FRACTURED AND THE GUIDEWIRE COULD NOT CROSS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20362022 ↗
• MalfunctionSep 25, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30AUG2024. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE PATIENT WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 1.20MM X 8MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, A NON-BOSTON SCIENTIFIC GUIDEWIRE COULD NOT CROSS THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT SHAFT POLYMER EXTRUSION RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305884 ↗
• MalfunctionApr 1, 2024Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THAT THE BALLOON CATHETER WAS STUCK ON THE GUIDEWIRE. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND NON-TORTUOUS LEFT CIRCUMFLEX CORONARY ARTERY. A 1.20MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE GUIDEWIRE WAS STUCK AND COULD NOT CROSS. THE BALLOON CATHETER AND GUIDEWIRE WERE REMOVED TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS STABLE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19016799 ↗