NC Emerge® H7493926715450Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729846574), received between Dec 18, 2020 and Mar 30, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Nonstandard Device; Material Rupture; Material Separation

  IT WAS REPORTED THAT BALLOON RUPTURE AND TIP DETACHMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A CALCIFIED VESSEL. A 4.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED TWICE; HOWEVER, THE PHYSICIAN BELIEVES THE BALLOON LIKELY RUPTURED DURING THE FIRST INFLATION. BECAUSE THERE WAS NO BLOOD RETURN IN THE INFLATION DEVICE, THE BALLOON WAS REINFLATED. UPON REMOVAL OF THE DEVICE, THE TIP OF THE CATHETER WAS FOUND TO BE DETACHED. THE PHYSICIAN SEARCHED FOR THE DETACHED COMPONENT UNDER X-RAY BUT WERE UNABLE TO LOCATE IT. THE PROCEDURE WAS DELAYED WHILE THE PHYSICIAN ATTEMPTED TO IDENTIFY THE MISSING TIP. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS EXPECTED TO MAKE A FULL RECOVERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24717415 ↗
• MalfunctionOct 15, 2025Nonstandard Device; Material Rupture; Device-Device Incompatibility; Nonstandard Device; Material Rupture; Device-Device Incompatibility

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED CORONARY ARTERY. A 4.50 MM X 15 MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. DURING THE INITIAL INFLATION AT 6 ATMOSPHERES FOR 3 SECONDS, THE BALLOON CAME INTO CONTACT WITH THE PROXIMAL END OF A PREVIOUSLY IMPLANTED STENT, RESULTING IN BALLOON RUPTURE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303563 ↗
• MalfunctionJul 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS, AND SEVERELY CALCIFIED CORONARY ARTERY. A 4.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT 12 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED SUCCESSFULLY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19779783 ↗
• MalfunctionOct 5, 2021Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  REPORTABLE BASED ON ADDITIONAL INFORMATION ON 15-SEPT-2021. IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 85% IN-STENT RESTENOSIS (ISR) TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND NON-TORTUOUS PROXIMAL SAPHENOUS VEIN GRAFT TO OBTUSE MARGINAL. A 4.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION AND WAS INFLATED TWICE AT 26 ATMOSPHERES FOR 20 SECONDS. THE DEVICE WAS FULLY DEFLATED, HOWEVER, IT WOULD NOT COME OUT OF THE GUIDE CATHETER. THE PHYSICIAN THEN PULLED EVERYTHING OUT TOGETHER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALSO STUCK ON THE WIRE. THE PHYSICIAN HAD TO REMOVE THE GUIDE, BALLOON, AND WIRE TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576716 ↗
• MalfunctionFeb 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS AN AREA OF IN-STENT RESTENOSIS LESION IN THE RIGHT CORONARY ARTERY. A LASER WAS INITIALLY USED TO MODIFY THE LESION. A 4.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED AND INITIALLY INFLATED AT 16 ATMOSPHERES. HOWEVER, DURING THE SECOND INFLATION AT 10 ATMOSPHERES (ATM) IT RUPTURED. IT WAS REPLACED WITH ANOTHER 4.50MM X 15MM NC EMERGE BUT IT ALSO RUPTURED DURING INITIAL INFLATION AT 14 ATM. SUBSEQUENTLY, A 4.50MM X 20MM NC EMERGE WAS ADVANCED BUT ALSO RUPTURED DURING THE SECOND INFLATION AT 16 ATM. THE DEVICES WERE COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A WOLVERINE CUTTING BALLOON FOLLOWED BY A NON-BSC BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369568 ↗
• MalfunctionFeb 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS AN AREA OF IN-STENT RESTENOSIS LESION IN THE RIGHT CORONARY ARTERY. A LASER WAS INITIALLY USED TO MODIFY THE LESION. A 4.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED AND INITIALLY INFLATED AT 16 ATMOSPHERES. HOWEVER, DURING THE SECOND INFLATION AT 10 ATMOSPHERES (ATM) IT RUPTURED. IT WAS REPLACED WITH ANOTHER 4.50MM X 15MM NC EMERGE BUT IT ALSO RUPTURED DURING INITIAL INFLATION AT 14 ATM. SUBSEQUENTLY, A 4.50MM X 20MM NC EMERGE WAS ADVANCED BUT ALSO RUPTURED DURING THE SECOND INFLATION AT 16 ATM. THE DEVICES WERE COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A WOLVERINE CUTTING BALLOON FOLLOWED BY A NON-BSC BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369564 ↗
• InjuryDec 18, 2020Material Rupture; Material Rupture

  IT WAS FURTHER REPORTED THAT THIS IS THE SAME CASE AS USER FACILITY MAUDE REPORT #MW5098430 IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED, TARGET LESION WAS LOCATED IN A CALCIFIED VESSEL. A 4.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST DILATATION OF A SYNERGY DRUG-ELUTING STENT. HOWEVER, DURING INFLATION AT 22 ATMOSPHERES, THE BALLOON RUPTURED. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, IT LOOKED LIKE A PIECE OF THE BALLOON WAS MISSING. NO BALLOON FRAGMENTS WERE FOUND VIA FLUOROSCOPY BUT THE PHYSICIAN THOUGHT A PIECE REMAINED IN THE PATIENT. ALL DEVICES WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11039902 ↗