NC Emerge® H7493926715350Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729846543), received between May 1, 2019 and Mar 30, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI). A 3.50 MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, UPON REMOVAL FROM THE HOOP, A SHAFT KINKED WAS NOTED. THE PHYSICIAN STILL DECIDED TO USE THE BALLOON, BUT A FRACTURE WAS SUBSEQUENTLY OBSERVED. THE PROCEDURE WAS PROLONGED BUT THERE WERE NO COMPLICATIONS REPORTED. THE PATIENT MADE A FULL RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714399 ↗
• MalfunctionJan 10, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 3.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INSERTION, IT WAS NOTICED THAT THE BALLOON FRACTURED TOWARDS THE DISTAL TIP. THE DEVICE WAS REMOVED IN ONE PIECE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21126156 ↗
• MalfunctionAug 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED CORONARY VESSEL. THE LESION HAD SIGNIFICANT NEOINTIMAL GROWTH AND THE PRESENCE OF TWO LAYERS OF STENT STRUTS IN CERTAIN SEGMENTS. A 3.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS PREPPED PROPERLY ACCORDING TO THE DIRECTION FOR USE (DFU) AND INFLATED TO NOMINAL PRESSURE. AFTER MULTIPLE BALLOON INFLATIONS THROUGHOUT THE LESION, THE BALLOON RUPTURED AT 12 ATMOSPHERES AFTER THE IT WAS INFLATED 2-3 TIMES AND THE BALLOON WAS REMOVED AND REPLACED BY A COMPETITIVE PRODUCT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007481 ↗
• MalfunctionMay 28, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT BROKE 30-40CM FROM THE HUB JUST OUTSIDE THE HEMOSTASIS VALVE. SUBSEQUENTLY, ANOTHER 3.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED, BUT THE SHAFT ALSO BROKE NEAR THE HUB. BOTH DEVICES WERE PULLED AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19407714 ↗
• MalfunctionApr 30, 2024Break; 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 3.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON FRACTURED. THE BROKEN COMPONENT WAS ABLE TO BE RETRIEVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217761 ↗
• MalfunctionFeb 29, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE NOT TORTUOUS AND MILDLY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 3.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INSERTION OF THE DEVICE THE SHAFT BROKE INSIDE THE GUIDE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS OR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18808857 ↗
• MalfunctionMar 17, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION, A 3.50MM X 15MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USED. HOWEVER, AFTER THE OPENING OF THE PACKAGE, THE SHAFT WAS BROKEN OUT OF THE HOOP. 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 13802989 ↗
• MalfunctionDec 1, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A LABELING ISSUE OCCURRED. WHILE OUTSIDE THE PATIENT, DURING PREPARATION OF A PERCUTANEOUS CORONARY INTERVENTION (PCI), A 3.50MM X 15MM NC EMERGE BALLOON WAS SELECTED FOR TREATMENT, BUT THE BALLOON INNER PLASTIC PACKAGING WAS NOTICED TO BE MISLABELED. IT WAS NOTED THAT A 3.50MM X 15MM NC EMERGE BALLOON APPEARED ON THE BOX, BUT THE INSIDE PLASTIC PACKAGING WAS NOTICED TO BE A 4.00MM X 8MM BALLOON. THE BALLOON CATHETER HUB WAS MARKED AS A 3.50MM X 15MM NC EMERGE BALLOON. NO DAMAGE TO THE PACKAGE WAS NOTED. THE 3.50MM X 15MM NC EMERGE BALLOON DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909218 ↗
• MalfunctionApr 30, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, DURING INSERTION, THE BALLOON SHAFT BROKE. THE DEVICE WAS REMOVED FRACTURED FROM THE PATIENT. NO DEVICE FRAGMENTS WERE LEFT INSIDE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW 3.50X15 DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11751015 ↗
• MalfunctionApr 5, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A DEVICE HAD AN INCORRECT LABEL. A PHYSICIAN HAD REQUESTED A 3.5 X 15MM NC EMERGE BALLOON CATHETER. THE SEALED BOX WAS LABELLED AS 3.5 X 15MM. THE SEALED INNER POUCH WAS LABELLED 4 X 8MM. THE ACTUAL BALLOON WAS A 3.5 X 15MM DESPITE THE LABELLING ON THE INNER POUCH. THE DEVICE WAS USED FOR THE PROCEDURE, WHICH WAS COMPLETED SUCCESSFULLY WITH NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11613847 ↗
• MalfunctionOct 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANDED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON BURST DURING FIRST INFLATION AT 14 ATMOSPHERES FOR 20 SECONDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10761791 ↗
• MalfunctionJun 23, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT MARKERBAND MISALIGNMENT OCCURRED. A 3.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHILE INFLATING THE BALLOON, IT WAS NOTED THAT THE MARKER BANDS WERE ABOUT 5-7MM APART. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10187208 ↗
• MalfunctionJun 23, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 3.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED AND INFLATED SUCCESSFULLY. HOWEVER, WHEN THE DEVICE WAS REMOVED, THE DELIVERY SHAFT WAS FRACTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10184748 ↗
• MalfunctionMar 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED CIRCUMFLEX CORONARY ARTERY. A 3.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED IN THE LESION. SUBSEQUENTLY, ANOTHER 3.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION; HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 15 SECONDS, IT ALSO RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9841382 ↗
• MalfunctionMar 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED CIRCUMFLEX CORONARY ARTERY. A 3.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED IN THE LESION. SUBSEQUENTLY, ANOTHER 3.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION; HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 15 SECONDS, IT ALSO RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9841294 ↗
• MalfunctionJul 8, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURED. A 3.50MM X 15MM NC EMERGE BALLOON CATHETER WAS SELECTED TO USE FOR DILATATION. HOWEVER, DURING INSERTION INTO THE GUIDE CATHETER, THE SHAFT OF THE BALLOON BROKE. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8768010 ↗
• MalfunctionMay 1, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50MM X 15MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE TO DILATE THE LESION. HOWEVER, IT WAS NOTED THAT THE SHAFT OF THE BALLOON CATHETER WAS BROKEN INSIDE THE PACKAGED RING. THE DEVICE NEVER ENTERED THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8569345 ↗