NC Emerge® H7493926708600Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729846345), received between Sep 30, 2022 and Jul 22, 2025 — classified as 2 injuries, 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Failure to Deflate; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT MAIN CORONARY ARTERY. A 6.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. THE BALLOON WAS INFLATED AT 8 ATMOSPHERES FOR 15 SECONDS. DURING REMOVAL, THE BALLOON WAS UNABLE TO BE PULLED BACK INTO THE 7FR GUIDING CATHETER DESPITE MULTIPLE ATTEMPTS TO APPLY NEGATIVE PRESSURE. THE BALLOON REMAINED WEDGED AT THE CATHETER TIP, AND THE PHYSICIAN CORKED THE PARTIALLY DEFLATED BALLOON INTO THE GUIDE CATHETER. BOTH DEVICES WERE REMOVED AS ONE UNIT ALTOGETHER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572331 ↗
• InjuryMay 21, 2025Break; Break

  IT WAS REPORTED VIA MEDSUN # 3902560000-2025-8066 THAT SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. DURING A CARDIAC CATHETERIZATION PROCEDURE, A 3.5 X 38MM NON-BOSTON SCIENTIFIC (BSC) STENT WAS SUCCESSFULLY DEPLOYED FROM THE LEFT MAIN (LM) TO MID LEFT CIRCUMFLEX ARTERY. THE PROXIMAL OPTIMIZATION TECHNIQUE WAS THE PERFORMED OF THE LM WITH A 6.00MM X 8MM NC EMERGE BALLOON CATHETER. UPON REMOVAL OF THE DEVICE, THE BALLOON SHAFT BROKE AND REMAINED IN THE LM. TO RETRIEVE THE BROKEN BALLOON SAFELY, A NON-BSC WIRE WAS ADVANCED PARALLEL TO ANOTHER NON-BSC WIRE, AND A 2.5 X 15MM NON-BSC BALLOON CATHETER WAS PARTIALLY DEPLOYED WITHIN THE GUIDE TO ANCHOR THE DEFLATED 6.0MM EMERGE BALLOON FRAGMENT. THE GUIDE, WIRES AND BALLOONS WERE THEN COMPLETELY REMOVED FROM THE BODY UNDER FLUOROSCOPY. THE EMERGE BALLOON WAS INSPECTED AND WAS REMOVED FROM THE BODY IN ITS ENTIRETY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22063492 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 6.00 MM X 8 MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT BROKE AT THE WIRE PORT. THE DEVICE WAS REMOVED ALONG WITH THE GUIDEWIRE AND THE BALLOON. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755152 ↗
• InjurySep 30, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DIFFICULTY REMOVAL AND SHAFT BREAK OCCURRED REQUIRING AN ADDITIONAL INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT MAIN (LM) ARTERY. A 6.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, DURING WITHDRAWAL AFTER DEFLATION, THE BALLOON WAS STUCK IN THE LM IMPLANTED STENT. WHEN PHYSICIAN APPLIED FORCE TO REMOVE THE BALLOON, THE SHAFT WAS FRACTURED AT ABOUT 15CM FROM THE DISTAL TIP. THE BALLOON AND THE REST OF THE SHAFT LEFT INSIDE THE PATIENT'S CORONARY ARTERY. THE FRAGMENT WAS SNARED OUT OF THE BODY SUCCESSFULLY. THIS REQUIRED A PROLONGED PROCEDURE WITH ADDITIONAL RADIATION AND BLOOD LOSS. THE PROCEDURE WAS COMPLETED WITH A 12X6 NC BALLOON CATHETER AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unintended Radiation Exposure

  MAUDE report 15510558 ↗