Emerge™ H7493919108200Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729807117), received between Feb 3, 2022 and Aug 11, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Material Rupture; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216492 ↗
• MalfunctionMar 3, 2026Nonstandard Device; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10FEB2026. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 8MM EMERGE? BALLOON CATHETER WAS ADVANCED FOR TREATMENT BUT COULD NOT PASS THROUGH THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498625 ↗
• MalfunctionFeb 9, 2026Entrapment of Device; Nonstandard Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A 2.00MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BECAME ENTRAPPED ON THE NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE AND COULD NOT BE WITHDRAWN. BOTH THE BALLOON AND THE NON-BSC GUIDEWIRE WERE SUBSEQUENTLY REMOVED TOGETHER. THE PROCEDURE WAS THEN COMPLETED USING 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 24291733 ↗
• MalfunctionJan 27, 2026Entrapment of Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. THE EMERGE BALLOON CATHETER WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. DURING THE PROCEDURE, THERE WAS SIGNIFICANT RESISTANCE BETWEEN THE DEVICES. THE BALLOON CATHETER COULD NOT BE WITHDRAWN AND WAS SUBSEQUENTLY REMOVED FROM THE BODY ALONG WITH THE GUIDEWIRE AND GUIDING CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS STABLE AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192297 ↗
• MalfunctionDec 5, 2025Nonstandard Device; Material Rupture; Nonstandard Device; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.00MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS MILDLY TORTUOUS AND MILDLY CALCIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23734149 ↗
• MalfunctionNov 3, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6)2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 8MM EMERGE? BALLOON CATHETER WAS ADVANCED FOR DILATION, BUT THE BALLOON COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED TIP DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457476 ↗
• MalfunctionJul 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED LEFT CORONARY ARTERY. A 2.00MM X 8MM EMERGE? BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED, AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385079 ↗
• MalfunctionJan 8, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTICED THAT THE DEVICE WAS LEAKING AIR. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105790 ↗
• MalfunctionApr 12, 2024Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 2.00MM X 8MM EMERGE BALLOON CATHETER WAS SELECTED FOR DILATATION. UPON REMOVAL OF THE BALLOON CATHETER, THE CENTRAL CAVITY OF THE BALLOON COULD NOT BE CROSSED AFTER PRESSURE DILATION. TIP DAMAGED WAS NOTED ON THE IMAGE DATA PROVIDED. THE BALLOON CATHETER AND GUIDEWIRE WERE REMOVED AS ONE UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS, AND THEIR CONDITION WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102218 ↗
• MalfunctionMar 27, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BALLOON TEAR WAS ENCOUNTERED. THE PATIENT WAS PRESENTED WITH PERSISTENT ATRIAL FIBRILLATION. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE BALLOON WAS NOT WELL SEALED AND AFTER THE BALLOON WAS INFLATED FOR 3-5 TIMES AT 12 ATMOSPHERES FOR 2 SECONDS, THE BALLOON WAS LEAKING GAS AND NON-VISIBLE SMALL TEARS WERE NOTED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618186 ↗
• MalfunctionOct 5, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 90% STENOSED, 24X3.5MM TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 2.00MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT BE PULLED OUT. THE BALLOON WAS PULLED OUT TOGETHER WITH THE GUIDEWIRE INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547143 ↗
• MalfunctionFeb 3, 2022Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16JAN2022. IT WAS REPORTED THAT FAILURE TO INFLATE WAS ENCOUNTERED. A 2.00MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES, THE BALLOON FAILED TO INFLATE. THE DEVICE WAS REMOVED COMPLETELY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13447908 ↗