NC Emerge® H7493926720220Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729846628), received between Feb 18, 2020 and Sep 2, 2025 — classified as 6 malfunctions.

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

• MalfunctionSep 2, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A PERIPHERAL ARTERY. A 2.25MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING DELIVERY TO THE TIBIAL REGION, THE DEVICE SNAPPED AT THE POLYMER JUNCTION OF THE BALLOON. THE DEVICE WAS RETRIEVED IN ITS ENTIRETY, WITH NO COMPONENTS RETAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION, AND NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932577 ↗
• MalfunctionJun 9, 2025Material Puncture/Hole; Device Contamination with Chemical or Other Material; Physical Resistance/Sticking; Material Puncture/Hole; Device Contamination with Chemical or Other Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT A SHAFT HOLE OCCURRED. A 2.25MM X 20MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING THE PREPARATION, A STRING-LIKE MATERIAL WAS OBSERVED COMING OUT FROM A HOLE IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22172059 ↗
• MalfunctionNov 26, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. A 2.25MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, THE PHYSICIAN MENTIONED THAT THE DEVICE WAS TOUGH TO RETRACT/REMOVE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20782044 ↗
• MalfunctionApr 15, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. A 2.25MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON DEFLATED SLOWLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19112328 ↗
• MalfunctionApr 15, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON SLOW DEFLATION OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING DEFLATION, THE BALLOON DEFLATED SLOWLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19111799 ↗
• MalfunctionFeb 18, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT CATHETER BECAME STUCK ON THE GUIDEWIRE AND A SHAFT BREAK OCCURRED. 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 9720508 ↗