NC Emerge® H7493926730350Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729846802), received between Dec 13, 2018 and Oct 31, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50MM X 30MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INSERTION, THE BALLOON SHAFT BROKE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE, AND NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23433401 ↗
• MalfunctionMay 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. A 3.50MM X 30MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21957419 ↗
• InjuryAug 26, 2020Material Rupture; Material Rupture

  IT WAS REPORTED VIA FACILITY MEDWATCH# (B)(4) THAT A BALLOON RUPTURE OCCURRED. A 3.50MM X 30MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED AFTER MULTIPLE HIGH PRESSURE INFLATIONS AND INTERVENTION WAS PERFORMED TO COMPLETE THE PROCEDURE. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 10455712 ↗
• MalfunctionJan 6, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20DEC2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. A 3.50MM X 30MM NC EMERGE BALLOON CATHETER WAS ADVANCED BUT THE SHAFT WAS BENT DURING INSERTION. THE PROCEDURE WAS COMPLETED WITH A 2.00MM X 30MM NC EMERGE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9554783 ↗
• MalfunctionDec 13, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). AFTER DEPLOYING A SYNERGY STENT IN THE DISTAL RCA, A 3.50MM X 30MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. HOWEVER, DURING REMOVAL, THE SHAFT HUNG UP AND ACCORDIONED ON THE WIRE. EVENTUALLY, THE DEVICE WAS SUCCESSFULLY REMOVED BY PULLING IT HARD. ANOTHER 2.50MM X 30MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST-DILATION IN PROXIMAL RCA AND ALSO GOT HUNG UP ON THE WIRE. THE DEVICE WAS REMOVED AS WELL AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8160742 ↗