Emerge™ H7493918915150Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729806189), received between Jan 23, 2019 and Sep 22, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Oct 24, 2019Class IITerminated

   Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.

   Z-0577-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2025Nonstandard Device; Device-Device Incompatibility; Difficult to Advance; Nonstandard Device; Device-Device Incompatibility; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26AUG2025. IT WAS REPORTED THAT DIFFICULTY TRACKING OVER THE WIRE WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. THE 1.50MM X 15MM EMERGE? BALLOON CATHETER WAS ADVANCED. HOWEVER, DURING INSERTION, THE GUIDEWIRE COULD NOT CROSS THE PORT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE POST-PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A TEAR ON THE OUTER LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23113743 ↗
• MalfunctionDec 7, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A 1.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE PROXIMAL SHAFT OF THE BALLOON BROKE WHILE TRYING TO ADVANCE. THE DETACHED PORTION WAS JUST OUTSIDE THE PATIENT AND THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18283069 ↗
• MalfunctionMay 3, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 1.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHILE TRACKING THE DEVICE OVER THE WIRE IN THE GUIDE, THE MID SHAFT OF THE BALLOON WAS BROKEN. THE BROKEN DEVICE WAS REMOVED ALONG WITH THE GUIDEWIRE AND ANOTHER INFLATED BALLOON, TO ENSURE THAT IT DID NOT GO INTO THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16865982 ↗
• MalfunctionOct 6, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY. DURING INSERTION OF A 1.50MM X 15MM EMERGE BALLOON CATHETER, THE SHAFT BROKE NEAR THE MIDDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 1.5X15MM EMERGE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12582950 ↗
• MalfunctionJul 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. CORONARY ANGIOGRAPHY WAS PERFORMED IN THE CATHERIZATION LAB AND IT WAS NOTED THAT THERE WAS A PLAQUE INFILTRATION IN THE PROXIMAL AND MIDDLE OF LEFT ANTERIOR DESCENDING ARTERY WITHOUT SIGNIFICANT STENOSIS. DIAGNOSTIC IMAGING SHOWS AN OCCLUSION IN THE PROXIMAL END, WITH OBVIOUS CALCIFICATION, AND ANOTHER BRANCH WAS FOUND IN THE OCCLUSION, AND PLAQUES WERE FOUND IN THE PROXIMAL END OF THE BRANCH. THERE WAS NO STENOSIS OBSERVED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY, WHILE PLAQUE INFILTRATION IN THE MIDDLE WITH ABOUT 20-30% STENOSIS. A 1.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES FOR 5 SECONDS, THE CALCIFICATION PUNCTURED THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12105119 ↗
• MalfunctionFeb 15, 2021Packaging Problem; Packaging Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21-JAN-2021 IT WAS REPORTED THAT THE PACKAGING WAS DAMAGED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. A 1.50MM X 15MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, THE PHYSICIAN FOUND THAT THE PACKAGE WAS DAMAGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11329800 ↗
• MalfunctionOct 5, 2020Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. THE 70% STENOSED, 5.0MMX 2.0MM, CONCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED RIGHT CORONARY ARTERY. A 1.50MM X 15MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, A HOLE IN THE INNER PACKAGE WAS FOUND AND THE STERILITY OF THE DEVICE GOT COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10631113 ↗
• MalfunctionJan 24, 2020Break; Break

  IT WAS REPORTED THAT BALLOON SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF RIGHT CORONARY ARTERY. AFTER ENGAGING THE LESION WITH A 7 FR GUIDE CATHETER, A 1.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHILE THE BALLOON WAS BEING PUSHED THROUGH THE GUIDE CATHETER, THE SHAFT SNAPPED IN TWO WITH A CLEAN BREAK APPROXIMATELY HALFWAY DOWN THE SHAFT. THE BALLOON WAS COMPLETELY REMOVED FROM THE BODY AND THE PROCEDURE COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9627687 ↗
• MalfunctionJan 23, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 1.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE THE SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8272013 ↗