NC Emerge® H7493926720250Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729846635), received between Dec 4, 2018 and Nov 3, 2025 — classified as 7 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2025Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED, REQUIRING INTERVENTION. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED VESSEL. A 2.50MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON ATTEMPTING TO RETRIEVE THE DEVICE AFTER INFLATION, THE DISTAL SHAFT FRACTURED. THE DETACHED PIECE WAS SUCCESSFULLY SNARED AND REMOVED FROM THE PATIENT IN ONE PIECE. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452172 ↗
• InjuryFeb 12, 2025Break; Difficult to Remove; Device Dislodged or Dislocated; Break; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND SHAFT BREAK OCCURRED RESULTING IN ADDITIONAL INTERVENTION. THE 90 TO 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. WHEN THE DEVICE WAS ADVANCED TOO FAR, THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON. THE REMOVAL WAS NOTED TO BE SOMEWHAT TIGHT. THE X-RAY IMAGING REVEALED THAT THE MIDDLE OF THE BALLOON DELIVERY SYSTEM HAD BROKEN OFF, AS THE BALLOON MARKERS WERE STILL VISIBLE INSIDE THE PATIENT. THE PHYSICIAN THEN ADVANCED A NON-BOSTON SCIENTIFIC GUIDE CATHETER OVER THE WIRE, SUCCESSFULLY RETRIEVING ONE PORTION OF THE BALLOON, BUT WAS UNABLE TO RETRIEVE THE OTHER. THE PHYSICIAN ALSO TRIED TO TRAP THE BALLOON FRAGMENT WITH ANOTHER BALLOON BUT WAS UNSUCCESSFUL, AND A BALLOON MARKER WAS STILL IN THE PATIENT. THE PROCEDURE WAS CANCELED AS THE PHYSICIAN COULD NOT GET A WIRE ACROSS THE LESION AGAIN. THE PHYSICIAN IMMEDIATELY SPOKE WITH THE SURGEONS AFTER THAT ABOUT BYPASS SURGERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE AT THE TIME OF THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21369334 ↗
• MalfunctionJan 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 2.50MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT 15 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. 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 21164069 ↗
• InjuryJul 24, 2024Material Rupture; Material Separation; Detachment of Device or Device Component; Material Rupture; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT A BALLOON ISSUED OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE OCCLUDED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND CALCIFIED POSTERIOR TIBIAL ARTERY. AFTER LEFT LEG ANGIO WAS PERFORMED, THERE WAS A RESIDUAL AREA OF CALCIFIC NON-EXPANSION. A 2.50 X 20MM NC EMERGE BALLOON WAS ADVANCED TO POST-DILATE A STENT. WHILE IN THE DISTAL SUPERFICIAL FEMORAL ARTERY, THE BALLOON RUPTURED AT 18 ATMOSPHERES AND SPLIT IN HALF, LEAVING BEHIND THE DISTAL RADIOPAQUE TIP OF THE BALLOON WHICH EMBOLIZED IN A SMALL GENICULATE BRANCH OFF THE KNEE. ANOTHER BALLOON WAS USED TO RESTORE FLOW BUT AN ATTEMPT TO SNARE THE DETACHED PIECE WAS NOT SUCCESSFUL. THE PATIENT FULLY RECOVERED.

  Patient problems: Foreign Body Embolism; Foreign Body In Patient

  MAUDE report 19817653 ↗
• MalfunctionMay 21, 2024Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29-APR-2024. IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. A 2.50MM X 20MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION WHEN REMOVED FROM THE INTER-TUBING, THE BALLOON WAS FOUND TO BE DEFECTIVE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A GUIDEWIRE LUMEN SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19360824 ↗
• MalfunctionFeb 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED MID RIGHT CORONARY ARTERY. A 2.50MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 12 ATMOSPHERES IN LESS THAN 10 SECONDS, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED, 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 18695993 ↗
• MalfunctionOct 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE MID RCA WAS PRE-DILATED WITH A 2.50MM X 20MM NC EMERGE BALLOON CATHETER. HOWEVER, DURING THIRD INFLATION AT 18 ATMOSPHERES (ATM) FOR 20 SECONDS, THE BALLOON RUPTURED. THE BALLOON WAS REPLACED WITH ANOTHER 2.50MM X 20MM NC EMERGE BALLOON CATHETER, BUT ALSO RUPTURED DURING THIRD INFLATION AT 20 ATM FOR 20 SECONDS. AFTER BALLOONING AND STENTING THE DISTAL RCA, PRE-DILATATION WAS PERFORMED ONCE MORE WITH A 3.25MM X 12MM NC EMERGE BALLOON CATHETER BUT IT ALSO RUPTURED DURING FOURTH INFLATION AT 20 ATM FOR 20 SECONDS. A 3.0X38 SYNERGY XD WAS PLACED AND POST DILATED WITH A 3.25X12 NC EMERGE BALLOON AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17870879 ↗
• MalfunctionOct 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE MID RCA WAS PRE-DILATED WITH A 2.50MM X 20MM NC EMERGE BALLOON CATHETER. HOWEVER, DURING THIRD INFLATION AT 18 ATMOSPHERES (ATM) FOR 20 SECONDS, THE BALLOON RUPTURED. THE BALLOON WAS REPLACED WITH ANOTHER 2.50MM X 20MM NC EMERGE BALLOON CATHETER, BUT ALSO RUPTURED DURING THIRD INFLATION AT 20 ATM FOR 20 SECONDS. AFTER BALLOONING AND STENTING THE DISTAL RCA, PRE-DILATATION WAS PERFORMED ONCE MORE WITH A 3.25MM X 12MM NC EMERGE BALLOON CATHETER BUT IT ALSO RUPTURED DURING FOURTH INFLATION AT 20 ATM FOR 20 SECONDS. A 3.0X38 SYNERGY XD WAS PLACED AND POST DILATED WITH A 3.25X12 NC EMERGE BALLOON AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17867832 ↗
• MalfunctionApr 19, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BREAK HAD OCCURRED. WHILE THE PHYSICIAN WAS ADVANCING A 2.5 X 20 NC EMERGE BALLOON CATHETER INTO THE GUIDE CATHETER WHEN THE SHAFT SEPARATED INTO TWO PIECES. THE BALLOON WAS STILL IN THE GUIDE AND WAS ABLE TO BE REMOVED WITH NO HARM TO THE PATIENT. A NEW BALLOON WAS OPENED AND THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686566 ↗
• MalfunctionFeb 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DETACHMENT OCCURRED. A 2.50MM X 20MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE, IT WAS NOTICED THAT THE BALLOON CAME RIGHT OFF THE SHAFT OF THE GUIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11310570 ↗
• MalfunctionDec 15, 2020Break; Break

  PER FACILITY MEDWATCH REPORT (B)(4). IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 MM X 20 MM NC EMERGE BALLOON CATHETER WAS USED FOR DILATATION. UPON REMOVING THE 2.5 X 15 MM NC BALLOON, THE SHAFT BROKE. IT WAS NOTICED IMMEDIATELY AND WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11015184 ↗
• MalfunctionOct 8, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85-90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INSERTION THROUGH THE GUIDE CATHETER, THE SHAFT BROKE. THE DEVICE WAS PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.50MM X 20MM EMERGE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10648416 ↗
• MalfunctionAug 7, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 20MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, WHEN LOADING ONTO THE WIRE, THE BODY OF THE BALLOON BROKE. IT WAS NOTED THAT THE WIRE WAS BENT PRIOR TO INSERTION AND IT SNAPPED WHEN ATTEMPTED TO STRENGHTEN IT OUT.

  Patient problems: No Patient Involvement

  MAUDE report 10380595 ↗
• InjurySep 4, 2019Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT SHAFT BREAK AND REMOVAL DIFFICULTIES OCCURRED. A 2.50MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 24 ATMOSPHERES, THE SHAFT BROKE. REMOVAL DIFFICULTY WAS NOTED SO AN OPTICAL COHERENCE TOMOGRAPHY WAS PERFORMED TO ASSESS THE SITUATION. FINALLY, THE WIRE AND THE BALLOON WERE COMPLETELY REMOVED BY SNARING. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8960176 ↗
• InjuryDec 12, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN FISTULA IN THE ARM. A 2.50MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS REMOVED FROM THE PATIENT, IT WAS NOTED THAT THE SHAFT BROKE OFF THE MONORAIL BALLOON PORTION OF THE CATHETER. THE PHYSICIAN WAS ABLE TO SNARE THE BALLOON AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8155965 ↗
• MalfunctionDec 6, 2018Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. IT WAS A SALVAGE CASE. THE PATIENT WAS FOUND DOWN IN THE FIELD AND THEY WERE TRYING TO REVIVE HIM. HOWEVER, THE PATIENT DID NOT CAME INTO THE LAB ALIVE. A 2.50MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE TOUHY BUT THE SHAFT BROKE ON THE WAY OUT. IT WAS PROBABLY PUSHED PRETTY HARD. IT WAS UNKNOWN IF THE PROCEDURE WERE FINISHED THAT THEY WERE PULLING EVERYTHING OUT. THE PATIENT DID EXPIRE BUT NOT BECAUSE OF THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8139750 ↗
• InjuryDec 5, 2018Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTY AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A FEMOROPERONEAL GRAFT. FOLLOWING STENT DEPLOYMENT, A 2.50MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, UPON REMOVAL OF THE BALLOON, RESISTANCE WAS ENCOUNTERED. ONCE THE DEVICE WAS REMOVED, IT BECAME APPARENT THAT THE BALLOON HAD SEPARATED FROM THE SHAFT AT THE CONNECTION OF THE SHAFT AND BALLOON PORTION. THE BALLOON PORTION THAT WAS LEFT IN THE PERIPHERY WAS REMOVED WITH A SNARE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND NO HARM WAS DONE TO THE PATIENT. RETURNED PRODUCT CONSISTED OF A NC EMERGE BALLOON CATHETER, .014" GUIDEWIRE, AND A SNARE DEVICE. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED MULTIPLE KINKS ON THE SHAFT. THE SHAFT AND GUIDEWIRE LUMEN IS SEPARATED APPROXIMATELY 126.4CM FROM THE HUB. MICROSCOPIC EXAMINATION REVEALED A TEAR ON THE SHAFT FROM THE EXIT NOTCH TO THE SEPARATION. FROM THE EXIT NOTCH TO THE SEPARATION ALSO APPEARS TO HAVE BEEN STRETCHED PRIOR TO SEPARATION. THE GUIDE WIRE USED IN THE CLINICAL PROCEDURE WAS RETURNED WITH THE DEVICE SO IT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8132495 ↗
• InjuryDec 4, 2018Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.50MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, DURING THE FIRST INFLATION AT NOMINAL PRESSURE FOR APPROXIMATELY 5 SECONDS, THE BALLOON RUPTURED. WHEN THE DEVICE WAS ATTEMPTED TO REMOVE, THE CATHETER GOT SEPARATED AND THE DISTAL PART OF THE BALLOON REMAINED IN THE PATIENT'S BODY. ABOUT THREE QUARTERS OF THE DEVICE WAS REMOVED. THE PATIENT WAS TRANSFERRED EMERGENTLY FOR SURGICAL INTERVENTION. THE BYPASSED PROCEDURE WAS SUCCESSFULLY PERFORMED AND THE RETAINED PORTION OF THE DEVICE WAS REMOVED FROM THE ARTERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ADMITTED DUE TO CHEST PAIN AND ACUTE MYOCARDIAL INFARCTION. THE PATIENT UNDERWENT AORTOCORONARY BYPASS GRAFTING X 5 DISUSE 4- VESSEL CORONARY ARTERY DISEASE. THE PATIENT WAS DISCHARGED TO AN INPATIENT REHABILITATION FACILITY AND WAS DOING WELL.

  Patient problems: No Code Available

  MAUDE report 8128295 ↗