Emerge™ Push H7493919020150Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729806035), received between Oct 21, 2019 and Jan 2, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2024Break; Break

  IT WAS REPORTED THAT DEVICE BREAK OCCURRED. A 1.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE DEVICE WAS NOTED TO BE DEFECTIVE AND BROKEN. THE DEVICE WAS PULLED AND REMOVED INTACT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18426088 ↗
• MalfunctionSep 26, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, THE TARGET LESION WAS IN AN AREA OF IN-STENT RESTENOSIS LOCATED IN THE TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHILE TRYING TO ADVANCE, THE SHAFT WAS KINKED AND AFTER SEVERAL ATTEMPTS, THE DEVICE EVENTUALLY BROKE. THE DEVICE WAS PULLED BACK AND REMOVED AS A UNIT WITH NO FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. THE LESION WAS REWIRED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER EMERGE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15486438 ↗
• MalfunctionMar 2, 2021Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 1.50MM X 20MM EMERGE PUSH BALLOON CATHETER WAS SELECTED TO USE. HOWEVER, DURING INSERTION, IMMEDIATE RESISTANCE WAS FELT WHILE PUTTING THE BALLOON INTO THE Y-ADAPTER AND GUIDE CATHETER AND THE BALLOON BROKE WHEN PULLED BACK. THE DEVICE WAS 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 11402224 ↗
• MalfunctionOct 21, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SHAFT HOLE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 1.50MM X 20MM EMERGE PUSH BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, A HOLE WAS NOTED IN THE SHAFT OF THE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9215677 ↗