Emerge™ H7493918912200Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 08714729806080), received between Oct 18, 2017 and Jul 30, 2026 — classified as 3 deaths, 3 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Break” (33 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 16, 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 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• DeathJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient death occurred.The patient underwent percutaneous coronary intervention (PCI) to the diagonal artery and then returned four days later for a PCI to the left anterior descending artery (LAD). During the second procedure, the LAD was successfully wired, the OptiCross imaging catheter was used for intravascular ultrasound (IVUS) examination of the target lesion without issue. It was noted that the motor drive used during IVUS appeared to make a strained noise when the catheter was running and being flushed at the same time. IVUS images were clear. A 2.00 x 12mm Emerge catheter was used to balloon the artery. Following the second balloon inflation, the patient became hypotensive and lost blood pressure. CPR was initiated immediately; however, the patient did not recover. The official cause of death was asystole.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 50091055 ↗
• MalfunctionNov 17, 2025Nonstandard Device; Material Puncture/Hole; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT SHAFT HOLE OCCURRED. A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, AN UNKNOWN WIRE FAILED TO EXIT THROUGH THE RECEIVING PORT AS INTENDED. INSTEAD, THE WIRE EXITED THE CATHETER SHAFT JUST DISTAL TO THE BALLOON. SUBSEQUENTLY, A HOLE WAS OBSERVED ON THE SIDE OF THE SHAFT, PROXIMAL TO THE RECEIVING PORT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578054 ↗
• MalfunctionSep 10, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY. A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT BROKE. THE DEVICE WAS REMOVED IN ONE PIECE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182334 ↗
• MalfunctionAug 15, 2024Break; Difficult to Remove; Detachment of Device or Device Component; Break; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT AND SHAFT BREAK OCCURRED. THE PATIENT WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. THE OVER 80% STENOSED COMPLEX, BIFURCATED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED DIAGONAL TO LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS USED AS A TRAPPING BALLOON WITHIN THE 6F NON-BOSTON SCIENTIFIC GUIDE CATHETER TO PIN THE GUIDEWIRE DURING EQUIPMENT EXCHANGES. AFTER A MICROCATHETER EXCHANGE, IT WAS NOTICEABLY IDENTIFIED THAT MOVING EQUIPMENT THROUGH THE GUIDE WAS CHALLENGING. AFTER PANNING WITH THE C-ARM, A BALLOON AND PART OF THE BALLOON SHAFT WAS STUCK IN THE GUIDE CATHETER. IT WAS THEN DECIDED TO REMOVE THE GUIDEWIRES AND THE ENTIRE GUIDE CATHETER SYSTEM IN ORDER TO RETRIEVE THE BALLOON. DURING REMOVAL, THE ENTIRE DISTAL PORTION OF THE BALLOON SHAFT WAS FRACTURED WITHIN THE GUIDE CATHETER, EITHER DURING OR AFTER USING THE BALLOON TO TRAP OUT THE MICROCATHETER IN WHICH SO MUCH RESISTANCE WAS BEING FELT. THE PHYSICIAN UPSIZED TO A 7F GUIDE CATHETER, RE-WIRED THE LESIONS AND PROCEEDED TO USE A 2.00MM X 12MM EMERGE BALLOON CATHETER TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19996487 ↗
• DeathJul 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. CORONARY ANGIOGRAPHY REVEALED DIFFUSE LESIONS IN THE DISTAL SEGMENT OF THE LEFT CIRCUMFLEX ARTERY (LCX) 70-80% STENOSIS. THE PROXIMAL SEGMENT OF THE OBTUSE MARGINAL BRANCH HAD A 90% STENOSIS. LONG LESIONS NOTED IN THE PROXIMAL AND MIDDLE SEGMENTS OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH STENOSIS OF 20-30%. THE PROXIMAL RIGHT CORONARY ARTERY (RCA) HAD A 30% STENOSIS, MIDDLE RCA SEGMENT 50% STENOSIS AND DISTAL RCA SEGMENT 50% STENOSIS. THE PATIENT WAS EXPERIENCING CHEST TIGHTNESS AFTER MEDICATION TREATMENT. THE FIRST LESION TREATED WITH INTERVENTION WAS THE OBTUSE MARGINAL BRANCH AND THE LCX. NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER AND GUIDEWIRE WERE PLACED AND A 2.0 X 12MM EMERGE BALLOON CATHETER WAS PRE DILATED IN THE PROXIMAL SEGMENT OF THE OBTUSE MARGINAL BRANCH AT 12 ATMOSPHERES FOR 5 SECONDS. A RECHECK ANGIOGRAPHY SHOWED CONTRAST AGENT RETENTION IN THE MIDDLE AND DISTAL PART OF LCX. THE BLOOD PRESSURE OF THE PATIENT DROPPED TO 80/50MMHG, AND HEART RATE WAS 80 BEATS PER MINUTE. FINGER OXYGEN 98%. IMMEDIATELY ADMINISTERED 20MG OF DOPAMINE INTRAVENOUSLY AND ADMINISTERED DOPAMINE AND NOREPINEPHRINE VIA INTRAVENOUS INFUSION TO MAINT

  Patient problems: Air Embolism; Asystole; Cardiac Arrest; Low Blood Pressure/ Hypotension; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 19867621 ↗
• MalfunctionJun 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS SELECTED FOR DILATION. HOWEVER, WHEN TRIED TO INFLATE IT ONCE, IT FAILED TO INFLATE AND A HOLE IN THE BALLOON WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19607509 ↗
• MalfunctionMay 8, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE SHAFT SNAPPED IN HALF OUTSIDE THE PATIENT WHEN TRIED TO ADVANCE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19269471 ↗
• MalfunctionApr 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS CORONARY ARTERY. A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT LESS THAN 12 ATMOSPHERES AND BEFORE REACHING NOMINAL PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19168938 ↗
• MalfunctionJan 26, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BROKE. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18585966 ↗
• MalfunctionDec 21, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INSERTION, THE MID SHAFT FRACTURED. THE DEVICE WAS PULLED OUT THROUGH THE GUIDE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18373343 ↗
• MalfunctionNov 9, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHILE TRYING TO PUSH THE DEVICE TO THE LESION, THE PROXIMAL SHAFT OF THE BALLOON FRACTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE SHAFT BROKE APPROXIMATELY 10-15 CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18102165 ↗
• MalfunctionAug 15, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 2.00MM X 12MM EMERGE BALLOON CATHETER, THE BODY OF THE BALLOON WAS NOTED TO BE SEPARATED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552530 ↗
• InjuryAug 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA USER MEDWATCH MW5118955 THAT BALLOON DETACHMENT OCCURRED. A 2.00MM X 12MM EMERGE BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON DETACHED FROM THE INTRAPROCEDURAL DELIVERY SYSTEM AND FELL OFF THE WIRE REQUIRING ADDITIONAL INTERVENTION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17443732 ↗
• InjuryJul 7, 2023Failure to Advance; Detachment of Device or Device Component; Device-Device Incompatibility; Failure to Advance; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE TORTUOUS ARTERY. A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON FAILED TO PASS THE SECOND LESION. IT WAS NOTED THAT THE BALLOON BECAME STUCK WITH THE PREVIOUSLY IMPLANTED STENT AND A PIECE TORE OFF THE END WHEN TRYING TO REMOVE THE BALLOON. MOST OF THE BALLOON AND WIRE WERE REMOVED BY PULLING THEM OUT AND THE REMAINING PIECE OF BALLOON WAS REMOVED WITH A SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17280515 ↗
• MalfunctionOct 12, 2022Break; Break

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS USED FOR DILATATION. HOWEVER, THE SHAFT OF THE DEVICE SNAPPED DURING INSERTION. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591274 ↗
• MalfunctionMay 13, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE SHAFT BROKE UPON REMOVAL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14398268 ↗
• MalfunctionFeb 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON BURST. THE DEVICE WAS REMOVED SUCCESSFULLY FROM THE PATIENT 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 13502011 ↗
• MalfunctionJan 26, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE SHAFT OF A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS NOTED TO BE BROKEN. THE DEVICE NEVER ENTERED THE PATIENT. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13360375 ↗
• MalfunctionJan 20, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 2.00MM X 12MM EMERGE BALLOON CATHETER, IT WAS NOTED THAT THE BALLOON SHAFT WAS SEPARATED FROM THE HYPOTUBE. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13311417 ↗
• MalfunctionJan 6, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. AFTER A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS PREPPED, IT WAS NOTED THAT THE SHAFT WAS FRACTURED ABOUT 15CM FROM THE HUB. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13184538 ↗
• MalfunctionDec 14, 2021Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. THE EMERGE WAS ADVANCED AND CROSSING DIFFICULTIES WERE ENCOUNTERED. DURING AN UNKNOWN TIME IN THE PROCEDURE THE EMERGE DELIVERY SYSTEM BROKE WHILE INSIDE THE PATIENT BODY. ALL THE PIECES WERE RETRIEVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006603 ↗
• MalfunctionDec 8, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHILE INTRODUCING THE BALLOON OVER THE WIRE, THE SHAFT OF THE BALLOON BROKE. THE DEVICE WAS REMOVED INTACT 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 12960494 ↗
• MalfunctionSep 13, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE BREAK OCCURRED. A 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL CIRCUMFLEX CORONARY AND DIAGONAL RESISTANT LESION. THE PHYSICIAN WIRED THE VESSEL AND ATTEMPTED TO BALLOON THE CIRCUMFLEX. THE LESION DID NOT EXPAND. A 1.50MM ROTAPRO WAS SELECTED FOR ATHERECTOMY. AFTER TWO PASSES, THE 1.50MM ROTAPRO WAS REMOVED. THE PHYSICIAN WIRED THE DIAGONAL LESION. A 1.25MM ROTAPRO BURR WAS ADVANCED. ATHERECTOMY WAS PERFORMED. A LARGE PERFORATION WAS NOTED AFTER USING THE 1.25MM ROTAPRO BURR. THE PHYSICIAN TAMPONADE THE VESSEL WITH A BALLOON AND A STENT WAS DEPLOYED TO COVER THE PERFORATION BUT IT WAS UNABLE TO GET TO AREA. THE PHYSICIAN REPOSITIONED THE 2.00MM X 12MM EMERGE BALLOON. THERE WAS DIFFICULTY REMOVING THE BALLOON. THE BALLOON PULLED APART AT THE DISTAL TO THE INNER CONNECTION. THE EMERGE BALLOON AND GUIDEWIRE WERE REMOVED TOGETHER AS ONE UNIT FROM THE PATIENT. THE GUIDEWIRE WAS ABLE TO BE REMOVED FROM THE EMERGE ONCE OUTSIDE THE PATIENT. THE PATIENT DIED POST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12459697 ↗
• MalfunctionSep 12, 2021Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE AND THERE WAS AN ISSUE PRESENT UPON OPENING THE PACKAGE. DURING PREPARATION, THE TIP OF THE BALLOON BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457984 ↗
• MalfunctionSep 12, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SECOND DIAGONAL ARTERY. A 2.00MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INSERTION, THE SHAFT SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457789 ↗