NC Emerge® H7493926715600Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729846604), received between Jun 17, 2022 and Jun 17, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2022Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26-MAY-2022. IT WAS REPORTED THAT REMOVAL DIFFICULTIES INTO THE GUIDE CATHETER AND DEVICE INTERACTION ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT MAIN ARTERY. AFTER STENT DEPLOYMENT, A 6.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST DILATION. AFTER THE BALLOON WAS INFLATED TO 12 ATMOSPHERES, THE DEVICE WOULD NOT COME BACK INTO THE GUIDE. AFTER SEVERAL ATTEMPTS OF PULLING NEGATIVE AND TRYING TO REMOVE THE BALLOON THROUGH THE GUIDE CATHETER, THE PHYSICIAN PULLED NEGATIVE ON THE BALLOON AND REMOVED THE 6FR GUIDE CATHETER MANUALLY TOGETHER WITH THE BALLOON AND THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON CATHETER FROZE ON WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14738881 ↗