NC Emerge® H7493926720300Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08714729846659), received between Jan 28, 2019 and Nov 17, 2025 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2025Nonstandard Device; Difficult to Remove; Material Rupture; Material Separation; Nonstandard Device; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT BALLOON RUPTURE, REMOVAL DIFFICULTY, AND TIP DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PROCEDURE WAS PERFORMED UNDER CONSCIOUS SEDATION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED PERONEAL ARTERY. AFTER INITIAL DILATION WITH A SERIES OF COMPLIANT BALLOONS, A 3.00 MM X 20 MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR FURTHER DILATION. DURING THE THIRD INFLATION AT 20 ATMOSPHERES FOR 40 SECONDS, THE BALLOON RUPTURED. SOME RESISTANCE WAS ENCOUNTERED DURING WITHDRAWAL, AND ONCE REMOVED, THE TIP OF THE CATHETER WAS FOUND TO BE SHEARED OFF, LEAVING THE MARKER AND A PORTION OF THE CATHETER INSIDE THE PATIENT. THE PHYSICIAN ATTEMPTED RETRIEVAL USING A SMALLER BALLOON BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS PERFORMED OVER A 0.014-INCH NON-BOSTON SCIENTIFIC GUIDEWIRE, AS THE ARTERY WAS ALREADY OCCLUDED. THE PROCEDURE WAS SUBSEQUENTLY ABORTED DUE TO THE INABILITY TO OPEN THE DISEASED VESSEL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23572344 ↗
• MalfunctionAug 29, 2024Entrapment of Device; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK ON THE GUIDEWIRE AND DIFFICULTY REMOVAL OCCURRED. A 3.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION FOR THE SECOND TIME. HOWEVER, THE BALLOON GOT STUCK WITH THE NON-BSC GUIDEWIRE AND IT WAS DIFFICULT TO RETRACT/REMOVE THE BALLOON. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20098388 ↗
• MalfunctionAug 29, 2024Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK ON THE GUIDEWIRE AND DIFFICULTY REMOVAL OCCURRED. A 3.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION FOR THE SECOND TIME. HOWEVER, THE BALLOON GOT STUCK WITH THE NON-BSC GUIDEWIRE AND IT WAS DIFFICULT TO RETRACT/REMOVE THE BALLOON. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20096934 ↗
• InjuryOct 3, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION FAILURE WHICH REQUIRES ADDITIONAL DEVICE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CIRCUMFLEX CORONARY ARTERY. A 3.00MM X 20MM FG NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INFLATED TO 16 ATMOSPHERES, HOWEVER; IT WOULD NOT DEFLATE INITIALLY. PHYSICIAN PULLED NEGATIVE TWICE AND THEN HAD TO USE SYRINGE TO MANUALLY DEFLATE FOR TWO MINUTES IN ORDER TO GET THE BALLOON BACK INTO THE GUIDE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17861761 ↗
• MalfunctionMay 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS MILDLY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A 3.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT NOMINAL PRESSURE FOR 5 SECONDS, THE BALLOON LOST ITS PRESSURE AND BURST. THE DEVICE WAS THEN REMOVED. ANOTHER 2.00MM X 12MM NC EMERGE BALLOON CATHETER WAS OPEN, BUT THE PLASTIC HUB FELL OFF AND LEAKING. THE DEVICE WAS REMOVED FROM THE PATIENT SUCCESSFULLY, AND NO DEVICE FRAGMENTS WERE LEFT INSIDE THE BODY. A NEW BALLOON WAS USED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16907732 ↗
• MalfunctionMar 14, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. A 3.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE DEVICE FAILED TO CROSS THE LESION AND THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537013 ↗
• MalfunctionFeb 3, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH ISCHEMIA AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 3.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. WHILE INSERTING THE BALLOON INTO THE GUIDE CATHETER, A SMALL KINK WAS CREATED WHEN THE SHAFT COLLAPSED. THE BALLOON CATHETER WAS CONTINUED TO BE USED AND WAS FURTHER INSERTED INTO THE GUIDE CATHETER. WHILE THE BALLOON CATHETER WAS BEING PRESSED FORWARD, THE SHAFT COMPLETELY BROKE OFF. THE DEVICE WAS PULLED OUT WITHIN THE GUIDE CATHETER. ANOTHER GUIDE CATHETER AND A NON-BOSTON SCIENTIFIC BALLOON WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16292728 ↗
• MalfunctionNov 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT NOMINAL ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15709485 ↗
• MalfunctionMay 3, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 3.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INTRODUCTION, THE DEVICE BROKE AT THE MIDSHAFT INSIDE THE GUIDE CATHETER. THE DEVICE WAS PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14269821 ↗
• MalfunctionSep 1, 2021Break; Break

  IT WAS REPORTED VIA FACILITY MEDWATCH MW5102685 THAT SHAFT BREAK OCCURRED. A 3.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON CATHETER BROKE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12411510 ↗
• MalfunctionJul 21, 2021Break

  BROKEN CATHETER BALLOON. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12210632 ↗
• MalfunctionApr 12, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00MM X 20MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE; HOWEVER, DURING INSERTION, THE DEVICE FRACTURED. THE PROCEDURE WAS COMPLETED WITH A NON BOSTON SCIENTIFIC DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649803 ↗
• MalfunctionJan 12, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION BUT THE BALLOON RUPTURED DURING INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11158021 ↗
• MalfunctionNov 11, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHILE REMOVING THE BALLOON FROM THE GUIDE, THE SHAFT OF THE BALLOON BROKE IN TWO PIECES. AT THE TIME THEY ALSO NOTED THERE WAS A KINK IN THE GUIDE. BOTH THE GUIDE AND THE BALLOON WERE REMOVED FROM THE BODY SAFELY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10823892 ↗
• MalfunctionSep 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.50MM X 15MM AND A 3.00MM X 20MM NC EMERGE BALLOON CATHETERS WERE ADVANCED FOR USE. HOWEVER, DURING INFLATIONS, BOTH BALLOONS WERE RUPTURED AT LOW ATMOSPHERE PRESSURES. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10540909 ↗
• MalfunctionMay 7, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE SHAFT OF THE BALLOON SNAPPED IN HALF WHEN THE PHYSICIAN TRIED TO PUSH IT IN TO THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10036695 ↗
• InjuryMar 16, 2020Break; Material Rupture; Detachment of Device or Device Component; Device-Device Incompatibility; Break; Material Rupture; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT BALLOON RUPTURE, BALLOON DETACHMENT AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 24 ATMOSPHERES, THE BALLOON RUPTURED. AS THE PHYSICIAN PULLED THE BALLOON BACK, THE BALLOON MATERIAL HUNG UP ON THE STENT AND CAME OFF THE SHAFT. THE TIP OF THE CATHETER WITH THE DISTAL MARKER WERE STILL ATTACHED TO THE BALLOON. A NON-BSC BALLOON WAS ADVANCED AND PUSHED THE BALLOON FRAGMENT IN THE TIP OF THE CATHETER. THE PHYSICIAN WENT BACK DOWN WITH ANOTHER SYNERGY STENT AND DEPLOYED IT TO TRAP THE BALLOON MATERIAL AND THE TIP OF THE CATHETER UP AGAINST THE OTHER STENT AND THE VESSEL WALL. POST DILATATION WAS PERFORMED AGAIN WITH A NON-BSC BALLOON CATHETER AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT DID WELL AND WAS OKAY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9837108 ↗
• MalfunctionFeb 18, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER BECAME STUCK ON THE GUIDEWIRE. THE TARGET LESION WAS LOCATED IN THE CALCIFIED IN-STENT RESTENOSIS LEFT ANTERIOR DESCENDING ARTERY. A 2.25MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED AND HAD TWO WIRES. HOWEVER, THE BALLOON GOT STUCK ON THE WIRE AND SO THE PHYSICIAN DECIDED TO PULLED EVERYTHING OUT FROM THE PATIENT'S BODY. AS SOON AS THESE DEVICES WERE OUT, THE BALLOON SHAFT BROKE UPON SEPARATING IT FROM THE WIRE. ANOTHER 3.0MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED ALONG WITH ONE WIRE. THE BALLOON DOES NOT SLIDE OVER THE WIRE AND GOT STUCK AS WELL AND SO IT WAS PULLED OUT FROM THE BODY. IT WAS THEN NOTED THAT THE LUMEN INTEGRITY WAS STRETCHED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT INJURY NOR ADVERSE EVENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9720510 ↗
• MalfunctionNov 13, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. POST ATHERECTOMY WITH A ROTAPRO, A 3.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 12 ATMOSPHERES FOR 2-3 SECONDS, THE BALLOON RUPTURED. ANOTHER 3.25MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED AND WAS ATTEMPTED TO BE INFLATED ONCE AT 12 ATMOSPHERES FOR 2-3 SECONDS BUT THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9315440 ↗
• MalfunctionOct 24, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. A 3.00MM X 20MM NC EMERGE BALLOON CATHETER WAS USED IN A PROCEDURE. HOWEVER, THE BALLOON GOT STUCK ON THE WIRE. THE PHYSICIAN WAS ABLE TO PULL EVERYTHING OUT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9235233 ↗
• MalfunctionMay 15, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE PHYSICIAN TRIED TO LOAD THE DEVICE ON THE WIRE, THE SHAFT BROKE AT THE MONORAIL JUNCTION POINT. A NON-BSC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8613377 ↗
• MalfunctionMay 2, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. DURING AN ATTEMPT TO INFLATE THE 3.00MM X 20MM NC EMERGE BALLOON, BLOOD WAS NOTED IN THE HUB AND THE BALLOON WAS PULLED OUT ON THE WIRE IN TWO PIECES. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8574676 ↗
• MalfunctionJan 28, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A SAPHENOUS VEIN GRAFT TO THE OBTUSE MARGINAL BRANCH. WHILE INSERTING A 3.00MM X 20MM NC EMERGE BALLOON CATHETER OVER THE WIRE AND INTO THE GUIDER, IT WAS NOTED THAT THE SHAFT BROKE IN HALF. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8282150 ↗