Emerge™ H7493918912300Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729806127), received between Sep 12, 2018 and Feb 7, 2024 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. TWO 3.00MM X 12MM EMERGE BALLOON CATHETERS WERE SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE DEVICES WERE FRACTURED UPON INSERTION INTO THE GUIDE. BOTH DEVICES WERE PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660697 ↗
• MalfunctionJan 26, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. TWO 3.00MM X 12MM EMERGE BALLOON CATHETERS WERE SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE DEVICES WERE FRACTURED UPON INSERTION INTO THE GUIDE. BOTH DEVICES WERE PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18585964 ↗
• MalfunctionJan 25, 2023Break; Break

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. A 3.00MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, HYPOTUBE BREAK WAS NOTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16243945 ↗
• MalfunctionSep 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON BURST OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 3.00MM X 12MM EMERGE BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, AT SECOND INFLATION, IT WAS NOTED THAT THE BALLOON GOT BURST. THE DEVICE WAS PULLED OUT COMPLETELY FROM THE PATIENT BODY. SUBSEQUENTLY, THE PHYSICIAN USES A 3.00X12MM EMERGE, 12X3.00MM NC QUANTUM APEX, 12X4.00MM NC QUANTUM APEX AND 10X2.50MM WOLVERINE BUT THE DEVICE WAS DIFFICULT TO ADVANCE AND GOT KINKED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410317 ↗
• MalfunctionApr 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.00MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT COMPLETELY AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14116196 ↗
• MalfunctionDec 8, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 16 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTICED THAT THE STENT STRUTS APPEARED TO BE LIFTED AND DEFORMED. THE DEVICE WAS REPLACED WITH ANOTHER STENT. A 3.00MM X 12MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION UPON INTRODUCTION, THE BALLOON SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962238 ↗
• InjuryOct 26, 2021Deflation Problem; Adverse Event Without Identified Device or Use Problem; Deflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED AND A PERFORATION OCCURED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 3.00MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON WOULD NOT DEFLATE. THE DEVICE WAS WITHDRAWN WHILE INFLATED. A PERFORATION OCCURRED. THE PATIENT CODED AND WAS THEN REVIVED. THE PHYSICIAN THEN PERFORMED A PERICARDIOCENTESIS WAS PERFORMED AS A PERICARDIAL EFFUSION WAS OBSERVED. A NON-BSC COVERED STENT WAS PLACED. AFTER THE PROCEDURE, THE PATIENT WAS TRANSPORTED TO THE INTENSIVE CARE UNIT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Cardiac Perforation; Perforation; Pericardial Effusion

  MAUDE report 12698506 ↗
• MalfunctionMar 15, 2021Break; Break

  IT WAS REPORTED THAT DURING PREPARATION A SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MILDLY CALCIFIED VESSEL. A 3.00MM X 12MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, THE SHAFT BROKE AT 75 CM FROM THE HUB AS IT WAS PULLED OUT OF THE CARRIER HOOP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11484838 ↗
• MalfunctionAug 26, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 3.00MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE BALLOON WAS REMOVED, IT WAS NOTICED THAT THE DELIVERY SHAFT WAS FRACTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10457520 ↗
• MalfunctionApr 11, 2019Break

  FROM STAFF: DR. WAS ADVANCING THE EMERGE BALLOON OVER THE WIRE AND THE BALLOON SHAFT BROKE IN HALF DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8503383 ↗
• MalfunctionOct 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION; HOWEVER, UPON INFLATION AT SIX ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. A 3.00MM X 12MM EMERGE BALLOON CATHETER WAS ALSO ADVANCED TO DILATE THE LESION; HOWEVER, UPON INFLATION AT SIX ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952122 ↗
• MalfunctionSep 12, 2018Break; Break

  SAME CASE AS MEDWATCH (B)(4). IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE BALLOON SHAFT GOT SEPARATED WHILE INSIDE THE GUIDE CATHETER. THE WHOLE SYSTEM WAS COMPLETELY REMOVED FROM THE PATIENT. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7868825 ↗