NC Emerge® H7493926715370Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729846550), received between Sep 28, 2020 and Jun 14, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND CALCIFIED CORONARY ARTERY. A 3.75MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE SHAFT FRACTURED IN THE DESCENDING AORTA AND SUBSEQUENTLY BROKE DURING ATTEMPTS TO REMOVE IT FROM THE BODY. THE DETACHED PORTION WAS SUCCESSFULLY REMOVED INTACT BY UTILIZING A TRAPPING METHOD. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19541527 ↗
• MalfunctionJun 11, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 3.75MM X 15MM NC EMERGE DRUG-ELUTING STENT WAS SELECTED FOR USE. DURING UNPACKING, A SMALL PIECE OF MATERIAL WAS NOTED ON THE BALLOON TIP INSIDE THE STERILE PACKAGE. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510799 ↗
• MalfunctionJan 3, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT WAS PRESENTED WITH CARDIOVASCULAR ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN MODERATE TO SEVERELY CALCIFIED AND TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD) AS WELL AS RADIAL ARTERY. A 3.75MM X 12MM, 3.75MM X 20MM, 3.75MM X 12MM, AND 3.75MM X 15MM NC EMERGE BALLOON CATHETERS WERE USED. HOWEVER, THE SHAFT OF THE FOUR CATHETERS WERE BADLY BENT AND BROKEN. THE DEVICES WERE BOTH PULLED OUT INTACT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED DIFFERENT BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16090912 ↗
• MalfunctionJul 22, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRODUCT WAS MISLABELED. A 3.75MM X 15MM NC EMERGE BALLOON CATHETER WAS REQUESTED FOR USE IN A CORONARY TREATMENT PROCEDURE. THE SCRUB TECHNICIAN SELECTED AN EMERGE BALLOON CATHETER FROM A BOX LABELED 3.75MM X 15MM NC EMERGE BALLOON CATHETER. THE EMERGE BALLOON CATHETER WAS PREPARED AND ADVANCED TO THE LESION. UNDER FLUOROSCOPY, THE BALLOON SIZE DID NOT LOOK ACCURATE. THE EMERGE BALLOON CATHETER WAS REMOVED FROM THE PATIENT. UPON INSPECTION IT WAS OBSERVED ON THE MANIFOLD THAT THE EMERGE WAS A 2.5MM X 12MM AND NOT 3.75MM X 15MM AS LABELED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12213166 ↗
• MalfunctionMar 4, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A BALLOON LEAK OCCURRED. A 3.75MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON FAILED TO HOLD PRESSURE AND IT WAS LEAKING FLUID. 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 11409000 ↗
• InjurySep 28, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED VIA USER/FACILITY MEDWATCH# (B)(4) THAT DEVICE ENTRAPMENT AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.75MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON WAS STUCK ON THE WIRE AND WHILE ATTEMPTING TO PULL IT OUT OF THE BODY, THE BALLOON WAS NOTED TO HAVE BROKEN OFF THE DELIVERY SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE MID LAD CONTAINED 95% STENOSIS AND 75% IN-STENT RESTENOSIS IN DISTAL LAD. DURING REMOVAL, FEMORAL ACCESS WAS GAINED AND A 6FR JR4 CAHETER AND A GOOSENECK CATHETER WERE USED TO SUCCESSFULLY REMOVE THE BALLOON TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10594170 ↗