Emerge™ H7493918908200Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729806509), received between Dec 17, 2018 and Apr 8, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.00MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON CATHETER BROKE WHILE INSERTING INTO THE SHEATH. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818940 ↗
• MalfunctionAug 5, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT BALLOON REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS, AND MILDLY CALCIFIED CORONARY ARTERY. A 2.00MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION; HOWEVER, AFTER DILATION WAS PERFORMED AND THE BALLOON DEFLATED, BALLOON REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE DEVICE WAS PULLED OUT OVER WIRE AND WAS REMOVED INTACT, AND NO PHYSICAL DAMAGE WAS NOTED WITH THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19911330 ↗
• MalfunctionJun 20, 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. A 2.00MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, AS THE TIME THEY WERE GOING TO INFLATE THE DEVICE, THE SHAFT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19576354 ↗
• MalfunctionAug 13, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING THE PROCEDURE, THE MID PART OF THE SHAFT BROKE. ANOTHER 2.00MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED; HOWEVER, THE SHAFT ALSO BROKE. BOTH DEVICES WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12319248 ↗
• MalfunctionMar 23, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.00MM X 8MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, WHEN PACKAGE WAS OPENED, THE SHAFT OF THE BALLOON WAS BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11557270 ↗
• MalfunctionMar 17, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.00MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON INITIAL INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11507936 ↗
• MalfunctionMar 8, 2021Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. AFTER A CRITICAL VESSEL WAS FIXED, A 2.00MM X 8MM EMERGE BALLOON CATHETER WAS INTRODUCED TO FIX A LESS URGENTLY STENOTIC VESSEL. THE BALLOON CATHETER WAS ADVANCED HALFWAY THROUGH A 6FR GUIDE CATHETER AND BECAME STUCK. THE DEVICE WAS PULLED BACK AND DURING ANOTHER ADVANCING ATTEMPT, THE HYPOTUBE SNAPPED IN HALF APPROXIMATELY 70CM FROM THE HUB. THE DEVICE WAS SUCCESSFULLY REMOVED ALONG WITH THE CATHETERS AND THE PROCEDURE WAS TERMINATED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440363 ↗
• MalfunctionFeb 24, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 2.00MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. THERE WERE TWO BALLOONS IN THE GUIDE CATHETER AND WHILE PUSHING, THE SHAFT KINKED AND WHEN PULLED BACK, THE SHAFT BROKE ABOUT 6 INCHES FROM THE HUB. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9746012 ↗
• MalfunctionOct 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.00MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION BELOW THE RATED BURST PRESSURE, THE BALLOON RUPTURED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9177631 ↗
• MalfunctionMar 12, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE OSTIAL CIRCUMFLEX ARTERY. AFTER A GUIDE WIRE WAS ADVANCED, A 2.00MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON LOADING THE DEVICE ON THE WIRE, IT WAS NOTED THAT THE BALLOON WAS FRACTURED. THE DEVICE DID NOT ENTER THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT HARM NOR COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8414014 ↗
• MalfunctionDec 17, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.00MM X 8MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, THE SHAFT BROKE. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8169840 ↗