NC Emerge® H7493926720600Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729846734), received between Oct 27, 2022 and Apr 18, 2025 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2025Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT SHAFT BREAK AND REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT RENAL ARTERY. A 6.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION OF EXISTING STENT. WHEN ATTEMPTING TO DEFLATE AND REMOVE THE BALLOON, THE CATHETER SHAFT BROKE WITH THE BALLOON PARTIALLY INFLATED MAKING IT DIFFICULT TO REMOVE. SIGNIFICANT BUNCHING OF THE CATHETER WAS IDENTIFIED WHEN THE BALLOON CATHETER WAS INSPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868292 ↗
• InjuryMar 26, 2025Break; Difficult to Remove; Detachment of Device or Device Component; Material Integrity Problem; Failure to Deflate; Break; Difficult to Remove; Detachment of Device or Device Component; Material Integrity Problem; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE PATIENT PRESENTED FOR ABDOMINAL AORTIC ANEURYSM REPAIR WITH A FENESTRATED GRAFT. THE 6.00 MM X 20 MM NC EMERGE BALLOON CATHETER WAS ADVANCED TO DILATE AN EXISTING LEFT RENAL STENT. DURING AN ATTEMPT TO DEFLATE AND REMOVE THE BALLOON, THE CATHETER SHAFT BROKE WITH THE BALLOON STILL PARTIALLY DEFLATED. EXTENSIVE WORK AND TIME, PLUS AN ADDITIONAL VASCULAR SURGERY PHYSICIAN WERE REQUIRED TO REMOVE THE FRAYED CATHETER AND UNFURLED BALLOON. THE PROCEDURE WAS ABORTED. THORACIC AND PARA-VISCERAL ANGIOGRAM DELINEATED NO EVIDENCE OF OVERT AORTIC INJURY AND NO EVIDENCE OF A TYPE 1A ENDO LEAK. THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT IN STABLE CONDITION AND WAS SCHEDULED FOR AN OPEN SURGICAL REPAIR OF THEIR AORTIC ANEURYSM. WHEN THE BALLOON CATHETER WAS INSPECTED, SIGNIFICANCE BUNCHING OF THE CATHETER WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697643 ↗
• InjuryOct 27, 2022Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A 6.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING REMOVAL, IT WAS NOTED THAT THE HYPOTUBE PORTION WAS MISSING AND IT WAS FOUND IN THE GUIDE. THE MISSING PIECE OF THE DEVICE WAS REMOVED BY SNARING. 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 15683165 ↗