Emerge™ H7493918915250Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 08714729806219), received between Aug 23, 2018 and Sep 2, 2025 — classified as 6 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT CORONARY ANGIOGRAPHY PROCEDURE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED WHILE DILATING THE CORONARY ARTERY. THE DEVICE WAS REPLACED WITH A NEW BALLOON, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935758 ↗
• InjuryOct 22, 2024Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 2.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED IN AN ATTEMPT TO TRAP A WIRE WITH THE BALLOON. HOWEVER, WHEN THE BALLOON WAS INFLATED AND THE MICROCATHETER PULLED BACK, THE BALLOON SHAFT BROKE AND BECAME LODGED IN THE CIRCUMFLEX ARTERY. A FAILED ATTEMPT WAS MADE TO SNARE THE DETACHED PIECE FOR REMOVAL, LEADING TO THE NEED FOR A STERNOTOMY SURGICAL INTERVENTION. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND STANDARD OF CARE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20505991 ↗
• MalfunctionJul 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON BURST. AN FG EMERGE MR, US 2.50 X 15MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION. DURING THE PROCEDURE, THE BALLOON HAD BURST. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT, AND ANOTHER SIMILAR DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19773181 ↗
• MalfunctionJul 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON BURST. AN FG EMERGE MR, US 2.50 X 15MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION. DURING THE PROCEDURE, THE BALLOON HAD BURST. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT, AND ANOTHER SIMILAR DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19773142 ↗
• MalfunctionJul 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON BURST. AN FG EMERGE MR, US 2.50 X 15MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION. DURING THE PROCEDURE, THE BALLOON HAD BURST. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT, AND ANOTHER SIMILAR DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. IT WAS LATER REPORTED THAT THE BALLOON BURST AFTER IT WAS INFLATED ONE TIME UP TO 12 ATM FOR 8 SECONDS. THE TARGET LESION WAS 20%-40% STENOSED, SEVERELY CALCIFIED, AND MODERATELY TORTUOUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19772900 ↗
• InjuryJul 5, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED, NECESSITATING ADDITIONAL INTERVENTION. CORONARY ANGIOGRAPHY WAS PERFORMED ON THE PATIENT. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MIDDLE-LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.50MM X 15MM EMERGE BALLOON CATHETER WAS USED TO DILATE THE LESION AT 12 ATMOSPHERES. RE-EXAMINATION OF THE ANGIOGRAPHY REVEALED THAT THERE WAS NO REFLOW IN THE LAD AND GAS EMBOLIZATION WAS CONSIDERED. DURING EXAMINATION OF THE BALLOON, IT WAS OBSERVED THAT THE DELIVERY SHAFT WAS LEAKING GAS. THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE TO 60/30 MMHG AND SEVERE CHEST PAIN WAS REPORTED. SUBSEQUENTLY, INTRACORONARY NORMAL SALINE FLUSHING AND INJECTION OF TIROFIBAN WERE ADMINISTERED. A STENT WAS IMPLANTED AFTER THE PATIENT'S CONDITION IMPROVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Air Embolism; Chest Pain; Low Blood Pressure/ Hypotension

  MAUDE report 19684692 ↗
• MalfunctionJun 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. DURING TREATMENT FOR CHRONIC TOTAL OCCLUSION, TWO 2.50 X 15 MM EMERGE BALLOONS WERE ADVANCED INTO A MICROCATHETER IN ATTEMPTS TO TRAP THE MICROCATHETER. BOTH BALLOONS BURST AFTER THE FIRST INFLATION AND WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON AND NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19628665 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 15MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE BALLOON WAS BENT/BROKEN AND COULD NOT BE USED IN CASE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19375244 ↗
• MalfunctionApr 26, 2024Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED VIA USER FACILITY OR VOLUNTARY MEDWATCH/MAUDE REPORT LIST # (B)(4). A 2.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WOULD NOT INFLATE OR DEFLATE CORRECTLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19193813 ↗
• MalfunctionApr 3, 2024

  ELDERLY MALE WITH HISTORY OF HYPERTENSION AND CHRONIC KIDNEY DISEASE. PROCEDURE: PTCA (PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY). THE EMERGE BALLOON WOULD NOT INFLATE OR DEFLATE CORRECTLY. ANOTHER ONE USED, NO KNOWN HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031144 ↗
• InjuryFeb 16, 2024Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY HEART DISEASE, EXERTIONAL FATIGUE, AND SHORTNESS OF BREATH. A 2.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING CATHETERIZATION OF THE DEVICE THE SHAFT BROKE. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS OR INJURIES REPORTED.

  Patient problems: Dyspnea; Fatigue; Ischemic Heart Disease; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18727462 ↗
• MalfunctionFeb 7, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 15MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, WHILE LOADING OVER THE WIRE, THE MID SHAFT BROKE OUTSIDE THE PATIENT'S BODY. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664416 ↗
• MalfunctionFeb 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH CHEST PAIN. THE TARGET LESION WAS LOCATED IN THE MIDDLE LEFT CIRCUMFLEX ARTERY. A 2.50 MM X 15 MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON SHEARED OFF THE WIRE SHAFT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658860 ↗
• MalfunctionJan 24, 2024

  ELDERLY MALE WITH HISTORY OF CORONARY HEART DISEASE, EXERTIONAL FATIGUE, AND SHORTNESS OF BREATH. PROCEDURE: LEFT HEART CATHETERIZATION. DURING THE CATHETERIZATION, THE BALLOON SHAFT BROKE. IT WAS REMOVED WITHOUT DIFFICULTY AND ANOTHER ONE USED WITHOUT ISSUES. MANUFACTURER RESPONSE FOR CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS, EMERGE (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: Insufficient Information

  MAUDE report 18569037 ↗
• MalfunctionJan 22, 2024Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED ONTO THE WIRE, BUT DIFFICULTY WAS ENCOUNTERED. HOWEVER, WHEN IT WAS PARTIALLY LOADED ONTO THE WIRE, THE MID SHAFT OF THE BALLOON WAS FRACTURED. THE BALLOON WAS REMOVED FROM THE GUIDE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS UNHARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18555831 ↗
• MalfunctionJan 18, 2024

  ADULT MALE WITH RECENT CHEST PAIN. PROCEDURE: LEFT HEART CATHETERIZATION AND PERCUTANEOUS INTERVENTION IN MID LEFT CIRCUMFLEX. THE BALLOON SHEARED OFF THE WIRE SHAFT AND HAD TO BE REMOVED. NO KNOWN HARM TO PATIENT. ANOTHER USED WITHOUT FURTHER PROBLEMS. MANUFACTURER RESPONSE FOR CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS, EMERGE¿ (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: Chest Pain

  MAUDE report 18534338 ↗
• MalfunctionOct 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA FACILITY MEDWATCH# (B)(4) THAT BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE OBTUSE MARGINAL BRANCH OF THE LEFT CIRCUMFLEX ARTERY. A 2.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT PORTION OF THE CATHETER SNAPPED INTO TWO PIECES. BOTH OF THE PIECES WERE STILL ON THE CORONARY WIRE AND ABLE TO BE PULLED INTO THE GUIDE CATHETER AND REMOVED FROM THE BODY. THE WHOLE SETUP EXCEPT FOR THE SHEATH HAD TO BE PULLED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016748 ↗
• MalfunctionOct 18, 2023

  CORONARY BALLOON CATHETER - SHAFT PORTION OF CATHETER SNAPPED INTO 2 PIECES. BOTH PIECES WERE STILL ON CORONARY WIRE AND MOVED INTO GUIDE CATHETER AND REMOVED FROM THE BODY. HAD TO PULL WHOLE SETUP OUT EXCEPT SHEATH.

  Patient problems: Insufficient Information

  MAUDE report 17956538 ↗
• MalfunctionJul 27, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING PREPARATION, WHEN A 2.50MM X 15MM EMERGE BALLOON CATHETER WAS PULLED OUT FROM THE HOOP, IT WAS NOTED TO BE SNAPPED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17406819 ↗
• MalfunctionJun 8, 2023Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

  IT WAS REPORTED, THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS, AND MODERATELY CALCIFIED FIRST OBTUSE MARGINAL ARTERY. A 2.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION. AND WHILE ATTEMPTING TO CROSS, IT WAS FOUND, THAT THE MID SHAFT BROKE AND KINKED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. AND THE PROCEDURE WAS COMPLETED WITH A 2.0X15MM EMERGE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17091571 ↗
• MalfunctionNov 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED VIA FACILITY MEDWATCH# (B)(4) THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH NEW ONSET OF SEVERE CHEST PAIN AND SHORTNESS OF BREATH. A 2.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON WAS NOT INFLATING. THE DEVICE WAS REMOVED AND IT WAS NOTICED THAT THERE WERE SMALL PINHOLES IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER EMERGE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15865042 ↗
• MalfunctionNov 16, 2022Inflation Problem; Material Puncture/Hole

  MID 50¿S FEMALE WITH NEW ONSET OF SEVERE CHEST PAIN AND SHORTNESS OF BREATH. PROCEDURE: EMERGENT DIAGNOSTIC HEART CATH WITH 3 STENTS. THE EMERGE BALLOON WAS NOT INFLATING. IT WAS REMOVED WITHOUT KNOWN HARM TO PATIENT AND THERE WERE SMALL PIN HOLES IN THE BALLOON. DELAY IN PROCEDURE, A SECOND EMERGE WAS USED WITHOUT PROBLEMS. MANUFACTURER RESPONSE FOR CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS, EMERGE¿ (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15804641 ↗
• MalfunctionNov 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.50MM X 15MM EMERGE BALLOON CATHETER WAS SELECTED FOR USED. HOWEVER, DURING PREPARATION, THE BALLOON FAILED TO INFLATE AS IT WAS NOTED LEAKING, IT SEEMS LIKE THERE WERE PINHOLES ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15772514 ↗
• MalfunctionAug 16, 2022Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10AUG2022. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN RIGHT CORONARY ARTERY. A 2.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT WAS KINKED OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234696 ↗
• MalfunctionAug 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED VESSEL. A 2.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN PRIMING AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15180196 ↗