NC Emerge® H7493926730250Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729846765), received between Dec 13, 2018 and Mar 1, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 2.50MM X 30MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, THE BALLOON RUPTURED AND THE BALLOON MATERIAL REMAINED IN THE MID RCA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13639714 ↗
• MalfunctionJan 26, 2022Material Rupture

  ATTEMPT PCI OF THE NATIVE RCA COMPLICATED BY BALLOON RUPTURE AND RETAINED BALLOON MATERIAL IN THE MID RCA. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13366944 ↗
• MalfunctionDec 13, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). AFTER DEPLOYING A SYNERGY STENT IN THE DISTAL RCA, A 3.50MM X 30MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. HOWEVER, DURING REMOVAL, THE SHAFT HUNG UP AND ACCORDIONED ON THE WIRE. EVENTUALLY, THE DEVICE WAS SUCCESSFULLY REMOVED BY PULLING IT HARD. ANOTHER 2.50MM X 30MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST-DILATION IN PROXIMAL RCA AND ALSO GOT HUNG UP ON THE WIRE. THE DEVICE WAS REMOVED AS WELL AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8160822 ↗