Emerge™ H7493918915350Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729806257), received between Feb 14, 2019 and Feb 24, 2025 — classified as 1 death, 1 injury, 7 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.

• InjuryFeb 24, 2025Break; Break

  IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED RESULTING IN PATIENT COMPLICATIONS. THE GREATER THAN 90% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED CORONARY ARTERY. A 3.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED THROUGH THE SAPHENOUS VEIN GRAFT (SVG) TO TREAT CORONARY ARTERY DISEASE (CAD). HOWEVER, UPON REMOVAL OF THE BALLOON AFTER INFLATION, THE DISTAL HALF OF THE BALLOON AND THE DISTAL CATHETER TIP DETACHED AND BECAME LODGED INSIDE THE VESSEL. THE PATIENT EXPERIENCED VESSEL OCCLUSION DUE TO THE BROKEN BALLOON REMAINING IN THE VESSEL. ATTEMPTS WERE MADE TO SNARE AND TRAP THE BALLOON WITH ANOTHER BALLOON, HOWEVER, THE DETACHED PIECE FLOATED OUT OF THE SVG INTO THE AORTIC CIRCULATION. THE PROCEDURE WAS NOT COMPLETED DUE TO VESSEL CLOSURE AND PATIENT INSTABILITY. PHARMACOLOGICAL AGENTS WERE ADMINISTERED TO LEAVE THE PATIENT IN A HEMODYNAMICALLY STABLE CONDITION.

  Patient problems: Foreign Body Embolism; Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 21454161 ↗
• DeathFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERORATION AND DEATH OCCURRED. ON (B)(6) 2025, THE PATIENT PRESENTED WITH STABLE ANGINA. THE SAME DAY THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION USING CUTTING BALLOON ANGIOPLASTY IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS PREDILATED WITH A 15 MM X 3.00 MM WOLVERINE CORONARY CUTTING BALLOON AT THE LAD. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED, AND ADDITIONAL DILATATION WAS PERFORMED WITH A 3.50 MM X 15 MM EMERGE BALLOON AND A 4.00 MM X 8 MM EMERGE BALLOON. AN ELLIS CLASS 3 PERFORATION IN THE PROXIMAL LAD OCCURRED WHICH WAS CONSIDERED TO HAVE BEEN CAUSED BY THE 3.50 X 15MM EMERGE BALLOON. THE PERFORATION WAS COVERED INITIALLY WITH A 4.00 X 20 MM NON-BOSTON SCIENTIFIC (NON-BSC) STENT AND PERICARDIOCENTESIS PERFORMED. A 3.00 X 20 MM NON-BSC STENT WAS IMPLANTED DISTAL TO THE INITIAL COVER STENT IN VIEW OF PERSISTENT EXTRAVASATION. CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED DUE TO PROFOUND HYPOTENSION. THE PATIENT WAS INTUBATED, AND VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO) WAS INSERTED. THE LEFT MAIN (LM) WAS RE-ENGAGED VIA THE LEFT FEMORAL ARTERY (LFA) USING AN 8FR NON-BSC GUIDING CATHETER. IT WAS SEEN T

  Patient problems: Cardiac Arrest; Extravasation; Low Blood Pressure/ Hypotension; Perforation; Pericardial Effusion

  MAUDE report 21449715 ↗
• MalfunctionOct 4, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A RIGHT CORONARY ARTERY. A 3.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON SHAFT SNAPPED INSIDE THE PATIENT. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538790 ↗
• MalfunctionJul 8, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. TWO 3.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12136087 ↗
• MalfunctionJul 8, 2021Break; 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 TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. TWO 3.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE SHAFT BROKE ON ONLY ONE EMERGE BALLOON CATHETER. THE EMERGE BALLOON CATHETER WAS PULLED BACK INTO THE GUIDE CATHETER AND WAS REMOVED. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12136081 ↗
• MalfunctionApr 8, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 3.50MM X 15MM EMERGE BALLOON CATHETER IT WAS NOTED THAT THE SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11636509 ↗
• MalfunctionOct 1, 2020Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2020. IT WAS REPORTED THAT INFLATION FAILURE AND SHAFT KINK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 3.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN INFLATION WAS ATTEMPTED, THE BALLOON FAILED TO INFLATE. THE DEVICE WAS REMOVED AND A KINK WAS NOTICED PROXIMAL TO THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SHAFT TEAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10617552 ↗
• MalfunctionAug 10, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY (RCA). A 3.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 16 ATMOSPHERES, THE BALLOON SPLIT IN HALF. THE DEVICE WAS REPLACED WITH A 4.0X20 NC QUANTUM BALLOON CATHETER AND THE RCA WAS STENTED WITH 3 STENTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10383731 ↗
• MalfunctionFeb 14, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50MM X 15MM EMERGE BALLOON CATHETER WAS SELECTED; HOWEVER, THE BALLOON RUPTURED BEFORE GOING INTO THE PATIENT. NO HARM OR COMPLICATIONS WERE DONE TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8341481 ↗