NC Emerge® H7493926712250Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08714729846376), received between Sep 18, 2018 and Apr 22, 2026 — classified as 3 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 18, 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-0579-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Material Rupture; Failure to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953119 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE DISTAL SHAFT TO THE BALLOON WAS FOUND TO HAVE SNAPPED. THE DEVICE WAS COMPLETELY REMOVED IN ONE PIECE, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT HAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414381 ↗
• MalfunctionMay 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED SUCCESSFULLY FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053537 ↗
• MalfunctionApr 23, 2025Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY AND SHAFT BREAK OCCURRED. A 2.50 MM X 12 MM NC EMERGE BALLOON CATHETER WAS ADVANCED AND USED FOR SIMULTANEOUS BALLOONING (KISSING BALLOON TECHNIQUE) FROM THE RAMUS AND LEFT CIRCUMFLEX INTO THE LEFT MAIN ARTERY. HOWEVER, UPON WITHDRAWAL, THE BALLOON ENCOUNTERED LOT OF RESISTANCE, AND IT BROKE. THE BALLOON WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21887826 ↗
• MalfunctionJan 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219786 ↗
• MalfunctionJan 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172044 ↗
• MalfunctionJan 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21171908 ↗
• InjurySep 10, 2024Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 23 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. WHEN THE DEVICE WAS REMOVED, THE SHAFT BROKE OFF INSIDE THE BODY AT 3 INCHES FROM THE DISTAL TIP. THE DETACHED PIECE WAS REMOVED SUCCESSFULLY WITH A SNARE AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20186478 ↗
• MalfunctionJul 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION, WHICH WAS STENOSED BY MORE THAN 80%, WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED TO THE LESION AND INFLATED. HOWEVER, DURING THE INITIAL INFLATION AT 18 ATMOSPHERES FOR LESS THAN 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS SUBSEQUENTLY REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822368 ↗
• MalfunctionJul 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 14 ATMOSPHERES FOR LESS THAN 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716568 ↗
• MalfunctionApr 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE OVER 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED RIGHT CORONARY ARTERY. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, UPON INFLATING TO THE NOMINAL PRESSURE OF 12 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT AND WAS FOUND TO BE DEFECTIVE. THE PROCEDURE WAS COMPLETED WITH A NEW 2.50X12MM NC EMERGE BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070074 ↗
• MalfunctionNov 28, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 12MM NC EMERGE WAS SELECTED FOR USED. HOWEVER, WHEN IT WAS ADVANCED INTO THE GUIDE CATHETER, THE MIDSHAFT OF THE DEVICE GOT FRACTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18219241 ↗
• MalfunctionJul 10, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED AORTO-OSTIAL RIGHT CORONARY ARTERY (RCA). A 3.50 X 28MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, AFTER INITIAL DEPLOYMENT OF THE STENT, INTERACTION WITH THE GUIDE CATHETER CAUSED AXIAL DEFORMATION OF THE STENT. AS A RESULT, SUBSEQUENT POST INFLATION BALLOONING WAS MADE DIFFICULT. A NEW WIRE WAS PLACED OUTSIDE THE FIRST ROW OF MEGATRON STENT STRUTS AND BALLOONS WERE USED IN A "CRUSH" TECHNIQUE TO CREATE AN OPENING. THEN, A NEW STENT WAS DEPLOYED AT THE OSTIUM RCA AND THE PROCEDURE WAS SUCCESSFUL. THE PATIENT THEN UNDERWENT ANGIOGRAM OF THE TARGET LESION LOCATED IN THE NON-TORTUOUS MID TO DISTAL RIGHT CORONARY ARTERY. A 2.50MM X 12MM NC EMERGE WAS ADVANCED AND DEPLOYED FOR TREATMENT. HOWEVER, DURING WITHDRAWAL, THE HYPOTUBE BROKE JUST PROXIMAL TO THE BALLOON AND REMAINED INSIDE THE PATIENT. A NEW STENT WAS PLACED TO PIN THE BALLOON FRAGMENT ONTO ANOTHER STENT TO AVOID MIGRATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17290587 ↗
• MalfunctionApr 10, 2023Break; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Break; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME (ACS). THE 90% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILD TO SEVERELY CALCIFIED VESSEL. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE DESPITE OF MULTIPLE ATTEMPTS THE DEVICE FAILED TO CROSS THE LESION. THE DEVICE WAS PULLED OUT AND REMOVED FROM THE PATIENT BODY BUT AS IT IS TAKING OUT OVER THE WIRE, IT WAS FOUND THAT THE SHAFT SNAPPED NEAR THE HYPOTUBE AND POLYMER CONNECTION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709684 ↗
• MalfunctionDec 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND NON-CALCIFIED PROXIMAL VESSEL. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, PRIOR TO INFLATION, IT WAS NOTICED THAT THERE WAS BLOOD IN THE HUB. THE BALLOON WAS STILL INFLATED BUT DID NOT HOLD INFLATION FOR A LONG PERIOD OF TIME. IT WAS NOTED THAT THE BALLOON RUPTURED, AND NOTHING WAS DETACHED. THE BALLOON WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16041955 ↗
• MalfunctionJul 14, 2022Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INTRODUCTION, THE BALLOON SHAFT BROKE OUTSIDE THE GUIDE CATHETER. THE DEVICE WAS PULLED OUT AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15015855 ↗
• MalfunctionJul 6, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT LABELLING ISSUE OCCURRED. A 2.50 X 12 NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTICED THAT THE DEVICE PACKAGE WAS FOR A COMPLIANT 2.50 X 12 EMERGE BALLOON CATHETER AND THE LOT NUMBER DID NOT MATCH ON THE OUTSIDE OF THE NC EMERGE BOX IT CAME IN. A 2.50 X 12 EMERGE BALLOON CAME IN A 2.50 X 12 NC EMERGE BOX. A NEW 12 NC EMERGE BALLOON CATHETER WAS USED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14940168 ↗
• MalfunctionJan 11, 2022Break; Break

  (B)(6) 2022 MP. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE DEVICE WAS FRACTURED AT THE MID PROXIMAL SHAFT BEFORE ENTERING THE BODY. 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 13232665 ↗
• InjuryDec 2, 2021Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE AND SHAFT BREAK OCCURRED. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. DURING INSERTION THE BALLOON RUPTURED AS BLOOD WAS OBSERVED WITHIN THE INFLATION DEVICE. WHEN ATTEMPTING TO REMOVE THE EMERGE BALLOON THE SHAFT DETACHED. ANOTHER BALLOON CATHETER WAS USED TO TRAP THE WIRE PART OF THE EMERGE BALLOON CATHETER AND THE DETACHED SHAFT WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12919104 ↗
• MalfunctionMay 11, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS INFLATED AT 12 ATMOSPHERES, THE WIRE BROKE IN HALF INSIDE THE 8F NON-BOSTON SCIENTIFIC GUIDE EXTENSION CATHETER. BOTH PIECES WERE REMOVED FROM THE PATIENT INTACT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810303 ↗
• MalfunctionApr 13, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE SHAFT WAS FRACTURED WITHIN 30 CENTIMETERS FROM THE HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11659968 ↗
• MalfunctionApr 12, 2021Break; Difficult to Advance; Material Deformation; Break; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS AN AREA OF IN-STENT RESTENOSIS LOCATED IN THE MODERATELY CALCIFIED MID CIRCUMFLEX ARTERY. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING INSERTION, THE PHYSICIAN FELT RESISTANCE AND UPON APPLYING FORWARD PRESSURE, IT RESULTED TO A FRACTURE IN THE MID SHAFT OF THE BALLOON. THERE WAS A PORTION HANGING OUT BUT IT WAS GRABBED AND REMOVED FROM THE PATIENT SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11652536 ↗
• MalfunctionOct 8, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 20 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER NC BALLOON. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10647249 ↗
• MalfunctionSep 22, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE CATHETER SHAFT BROKE. THE DEVICE NEVER ENTERED THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10569771 ↗
• MalfunctionSep 9, 2020Material Rupture; Material Rupture

  IT WAS REPORTED VIA USER/FACILITY MEDWATCH# (B)(4) THAT BALLOON RUPTURE OCCURRED. THE 70-80% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER ENGAGING A 6 FR EBU 3.0 GUIDE CATHETER AND PLACING A NON-BSC WIRE, PRE-DILATATION WAS PERFORMED WITH A 2.0 COMPLIANT BALLOON. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INITIALLY INFLATED AT 22 ATMOSPHERES FOR 69 SECONDS; HOWEVER, DURING THE SECOND INFLATION AT 20 ATMOSPHERES FOR 22 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10509001 ↗