NC Emerge® H7493926720320Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729846666), received between Jan 2, 2019 and Jan 31, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.25MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, UPON INFLATION, THE BALLOON RUPTURED. WHEN THE BALLOON WAS REMOVED, THE PHYSICIAN NOTED THAT IT LOOKED UNUSUAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO KNOWN PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9653249 ↗
• MalfunctionNov 13, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. POST ATHERECTOMY WITH A ROTAPRO, A 3.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 12 ATMOSPHERES FOR 2-3 SECONDS, THE BALLOON RUPTURED. ANOTHER 3.25MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED AND WAS ATTEMPTED TO BE INFLATED ONCE AT 12 ATMOSPHERES FOR 2-3 SECONDS BUT THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9315527 ↗
• MalfunctionFeb 12, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.25MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED THROUGH A NON BSC BLEEDBACK CONTROL VALVE IN TO THE GUIDE CATHETER. HOWEVER, DURING ADVANCEMENT, IT WAS NOTED THAT THE BALLOON SNAPPED INTO PIECES. THE DEVICE NEVER ENTERED THE PATIENT, JUST THE BLEEDBACK CONTROL VALVE AND GUIDE CATHETER. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8332910 ↗
• MalfunctionJan 2, 2019Break; Break

  IT WAS REPORTED A SHAFT BREAK OCCURRED. A 3.25MM X 20MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, UPON LOADING THE DEVICE ON THE WIRE, IT WAS NOTICED THAT THE SHAFT BROKE IN HALF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8209172 ↗