NC Emerge® H7493926715200Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729846482), received between May 25, 2021 and Mar 18, 2024 — classified as 1 death, 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. A 2.00MM X15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BROKE IN HALF. BOTH PARTS OF THE BALLOON WERE REMOVED ALONG WITH THE GUIDEWIRE AND GUIDE CATHETER. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921530 ↗
• MalfunctionJan 11, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 2.00MM X15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON DEFLATED SLOWLY. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499522 ↗
• MalfunctionMay 3, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. A 2.00MM X15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, DURING THE PROCEDURE, TROUBLED PUSHING THE BALLOON WAS FELT AND THE BALLOON WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16863701 ↗
• DeathNov 21, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2021, AN INDEX PROCEDURE WAS PERFORMED AND IMPLANTED TWO SYNERGY XD DRUG-ELUTING STENTS (DES) AND TWO SYNERGY MEGATRON DES IN THE OSTIAL LEFT MAIN ARTERY (LM), OSTIAL TO PROXIMAL CIRCUMFLEX ARTERY (CX), MID LEFT ANTERIOR DESCENDING ARTERY (LAD), AND OSTIAL TO PROXIMAL FIRST DIAGONAL ARTERY (DIAG1). A CHRONIC TOTAL OCCLUSION WAS DOCUMENTED IN THE RIGHT CORONARY ARTERY (RCA). IN (B)(6) 2022, THE PHYSICIAN ATTEMPTED TO TREAT THE RESTENOSIS FOUND IN THE OSTIAL CX. IT WAS BELIEVED THAT THE STENTS IMPLANTED IN THE OSTIAL CX AND LM WERE NOT FULLY EXPANDED DURING THE INDEX PROCEDURE WHICH LED TO THE UNINTENTIONAL PASSING OF GUIDEWIRES THROUGH THESE UNOPPOSED STENT STRUTS. A 2.00 X 15MM EMERGE BALLOON CATHETER WAS ADVANCED TO THE LM AND INTO THE CX WHERE IT WAS INFLATED TO 10 ATMOSPHERES (ATM), BUT THE BALLOON RUPTURED. THE PHYSICIAN ATTEMPTED TO REMOVE THE 2.00 X 15MM EMERGE BUT A SIGNIFICANT RESISTANCE WAS ENCOUNTERED. THE BALLOON GOT STUCK IN THE VESSEL AND WHEN AN EXTREME FORCE WAS APPLIED TO REMOVE THE DEVICE, THE DISTAL HALF OF THE BALLOON FRACTURED AND REMAINED STUCK IN THE LM AND CX. IN ORDER TO TRAP AND RECOVER THE DISTAL SHAFT OF TH

  Patient problems: Foreign Body In Patient

  MAUDE report 15839657 ↗
• MalfunctionSep 3, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT SHAFT BREAK AND BALLOON DETACHMENT OCCURRED. A 2.00MM X15MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, UPON REMOVAL OF THE BALLOON CATHETER FROM THE HOOP, THE SHAFT WAS BROKEN AND THE BALLOON FELL OFF THE SHAFT. THE DEVICE WAS NEVER USED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421586 ↗
• InjuryMay 25, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK REMAINED IN THE PATIENT. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN ANASTOMOSIS OF LEFT INTERNAL MAMMARY ARTERY TO LEFT ANTERIOR DESCENDING ARTERY (LIMA/LAD). A 2.00MM X15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING 2ND INFLATIONS THE DEVICE FRACTURED. THE DISTAL PORTION OF THE BALLOON WAS LEFT IN THE PATIENTS BODY AND SOME PARTS WERE ABLE TO BE REMOVED. ANOTHER WIRE WAS USED TO NAVIGATE THE DEVICE FRAGMENTS BUT IT WAS UNSUCCESSFUL AND THE PROCEDURE WAS CANCELLED OR RESCHEDULED. IT WAS FURTHER REPORTED THAT THE PATIENT HAS BEEN DISCHARGED AND WAS BEING TREATED BY MEDICAL MANAGEMENT. THERE WERE NO PATIENT COMPLICATIONS DUE TO UNRETRIEVED DEVICE FRAGMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11880098 ↗