Emerge™ H7493918920250Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08714729806325), received between Nov 13, 2018 and Nov 5, 2024 — classified as 4 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BROKE. THE PROCEDURE COMPLETED USING AN ALTERNATE METHOD AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20614248 ↗
• MalfunctionJan 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE; HOWEVER, WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE, THE BALLOON SIMPLY FELL APART. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509284 ↗
• InjuryNov 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE AND DISSECTION OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.50MM X 20MM FG EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION AT 28 ATMOSPHERES FOR 10 SECONDS, THE BALLOON BODY MATERIAL BURST, AND THE DEVICE WAS DIRECTLY PULLED FROM THE PATIENT. IT WAS NOTED THAT A NON-FLOW-LIMITING DISSECTION OCCURRED. THE PROCEDURE TIME WAS PROLONGED, BUT THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Vascular Dissection

  MAUDE report 18156102 ↗
• MalfunctionSep 7, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING LOADING THE BALLOON ON THE NON-BOSTON SCIENTIFIC (BSC) WIRE, THE MID SHAFT OF THE STAINLESS-STEEL ROD WAS SNAPPED IN HALF. THE DEVICE WAS PULLED OUT FROM THE WIRE, AND THE PROCEDURE WAS COMPLETED WITH NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17696779 ↗
• MalfunctionMar 6, 2023Device Difficult to Setup or Prepare

  EARLY 70¿S FEMALE WITH NEW ONSET OF CHEST PAIN. PROCEDURE: HEART CATH AND EMERGENT PERCUTANEOUS CORONARY INTERVENTION. BOSTON SCIENTIFIC EMERGE MONORAIL BALLOON WOULD NOT LOAD ONTO THE WIRE. ANOTHER USED, NO KNOWN HARM TO PATIENT-DELAYMANUFACTURER RESPONSE FOR CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS, EMERGE¿ (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16484773 ↗
• MalfunctionFeb 27, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE PATIENT WAS BEING TREATED FOR ATHEROSCLEROSIS AND UNDERWENT HEART CATHETERIZATION. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON FAILED TO INFLATE. THE PROCEDURE WAS CANCELLED OR RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT NO VISIBLE PINHOLE WAS NOTED ON THE BALLOON MATERIAL AND THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16449552 ↗
• MalfunctionSep 8, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD) AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). THE 95% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE; HOWEVER, THE SHAFT BROKE AT THE TRANSITION OF THE HYPOTUBE TO THE BALLOON UPON REMOVAL FROM THE HOOP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15379156 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT SHAFT FRACTURE OCCURRED. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INSERTION, THE DEVICE FRACTURED AT THE MIDDLE OF THE 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 13721891 ↗
• InjuryFeb 14, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED AND PATIENT EXPERIENCED ANXIETY. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, THE SHAFT WAS FRACTURED AND THE PATIENT EXPERIENCED ANXIETY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Anxiety

  MAUDE report 13523268 ↗
• MalfunctionNov 12, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED BY SIMPLY PULLING OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12802774 ↗
• MalfunctionSep 21, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. HOWEVER, UPON REMOVAL OF THE BALLOON, THE PROXIMAL SHAFT WHICH IS CLOSER TO THE HUB OF THE BALLOON BROKE. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507817 ↗
• MalfunctionAug 25, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING REMOVAL, THE DEVICE BROKE INSIDE THE GUIDE CATHETER. THE DEVICE WAS REMOVED BROKEN IN TWO PIECES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 80% STENOSED AND MILDLY TORTUOUS. THE BALLOON DID NOT ENTER THE PATIENT'S BODY AND IT APPEARED TO BE KINKED RIGHT OUT OF THE HOOP. WHEN THE BALLOON WAS LOADED ON THE GUIDEWIRE, THE HYPOTUBE BROKE ABOUT 90CM FROM THE DISTAL TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER EMERGE BALLOON OF THE ASE SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367445 ↗
• MalfunctionJul 22, 2021Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02-JUL-2021. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL PART OF LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS FOUND OUT THAT THE CONNECTING PART OF THE BALLOON WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED MARKERBAND DAMAGE AND HYPOTUBE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214833 ↗
• InjuryMar 17, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT AIR EMBOLISM OCCURRED AND PATIENT WENT INTO CARDIAC ARREST. THE TARGET LESION WAS LOCATED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING CORONARY ATHERECTOMY, A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. PRIOR TO INFLATING THE BALLOON, THE PHYSICIAN PULLED NEGATIVE AND PROCEEDED TO INFLATE THE BALLOON. HOWEVER, THE BALLOON FAILED TO INFLATE AND WAS SUBSEQUENTLY REMOVED. ANGIOGRAM WAS PERFORMED AND REVEALED THAT THE CORONARY ARTERIES WERE FULL OF AIR. THE PATIENT WENT INTO CARDIAC ARREST AND WAS PLACED ON A VENTILATOR. THE PATIENT WAS REVIVED AND THE PROCEDURE WAS COMPLETED. POST PROCEDURE, TECHNICIAN TESTED THE BALLOON AND NOTED THAT THERE WAS A HOLE IN THE SHAFT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Air Embolism; Cardiac Arrest

  MAUDE report 11508481 ↗
• MalfunctionMar 15, 2021Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION OF A NON-BSC IMPLANTED STENT. THE EMERGE BALLOON CATHETER WAS FULLY DEFLATED PRIOR WITHDRAWAL. RESISTANCE WAS FELT DURING WITHDRAWAL. THE NON-BSC IMPLANTED STENT MIGRATED FROM THE TARGET LESION. ADDITIONAL STENTING WAS REQUIRED AS A RESULT OF THE MIGRATED NON-BSC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11483710 ↗
• InjuryFeb 3, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.50 MM X 20 MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INFLATION, IT WAS NOTICED THAT THE CATHETER SHAFT WAS BROKEN. THE PROXIMAL PORTION OF THE BALLOON WAS REMOVED BUT THE DISTAL PORTION WAS LEFT IN THE ARTERY. THE PHYSICIAN THEN PERFORMED SNARING. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11276673 ↗
• MalfunctionAug 12, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED, 20MMX.5MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, THE BALLOON DELIVERY SHAFT WAS FRACTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10395970 ↗
• MalfunctionJun 25, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN CROSSING THE LESION, THE DEVICE WAS FRACTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10195983 ↗
• MalfunctionJun 9, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE SHAFT OF THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10135495 ↗
• MalfunctionMar 3, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING, RAMUS AND CIRCUMFLEX ARTERIES. AFTER THE WIRES WERE PLACED IN THE LESIONS, A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, IT WAS NOTED THAT THE BALLOON WOULD NOT INFLATE AND WHEN IT WAS REMOVED, THE SHAFT BROKE PART OF THE BALLOON INSIDE THE GUIDE APPROXIMATELY 100 CM FROM THE HUB. EVERYTHING WAS REMOVED AS ONE UNIT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9781293 ↗
• MalfunctionDec 30, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS USED IN A PROCEDURE. HOWEVER, DURING ADVANCING, THE SHAFT BECAME SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9530424 ↗
• MalfunctionDec 9, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE, IT WAS NOTICED THAT THE FRONT END OF THE BALLOON WAS FRACTURED. 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 Consequences Or Impact To Patient

  MAUDE report 9439368 ↗
• MalfunctionDec 5, 2019Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20NOV2019. IT WAS REPORTED THAT BALLOON LEAK AND SHAFT KINK OCCURRED. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTICED THAT THE BALLOON CATHETER WAS KINKED. WHEN PRESSURE WAS EXERTED, THE BALLOON WAS FOUND LEAKING GAS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT BALLOON SHAFT WAS DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9416847 ↗
• MalfunctionNov 5, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON HAD DEFLATION ISSUE. A 2.50MM X 20MM EMERGE BALLOON WAS SELECTED FOR USE. AT THE END OF THE PROCEDURE, IT WAS NOTED THAT THE ATTACHMENTS TO THE INDEFLATOR SEEMED TO SLIP OFF AND NOT STAY ATTACHED. SUBSEQUENTLY, THE EMERGE BALLOON WAS NOT DEFLATING EASILY. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9280621 ↗
• MalfunctionOct 18, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, WHILE LOADING THE DEVICE ONTO THE WIRE, THE SHAFT BROKE INTO TWO. THE DEVICE WAS NEVER USED AND THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9208372 ↗