NC Emerge® H7493926712220Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729846369), received between Nov 12, 2020 and Dec 11, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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.

• InjuryDec 11, 2025Break; Nonstandard Device; Device-Device Incompatibility; Break; Nonstandard Device; Device-Device Incompatibility

  IT WAS REPORTED VIA MEDSUN REPORT (B)(4) THAT SHAFT BREAK OCCURRED, RESULTING PATIENT COMPLICATIONS. THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY WITH A NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER. ONE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY LAD) AND ANOTHER IN THE 1ST DIAGONAL BRANCH. A NON-BSC WIRE WAS PASSED INTO THE 1ST DIAGONAL AND ANOTHER NON-BSC WIRE WAS PLACED DOWN THE LAD. MULTIPLE BALLOONS WERE USED TO OPEN THE 1ST DIAGONAL AND THEN THE LAD. AFTER BALLOONING, INTRAVASCULAR ULTRASOUND WAS PERFORMED WHICH SHOWED UNDER EXPANSION IN THE REGION OF THE PREVIOUSLY PLACED STENT IN THE 1ST DIAGONAL. A 2.25MM X 12MM NC EMERGE BALLOON CATHETER WAS DELIVERED TO THE 1ST DIAGONAL STENT AREA AND INFLATED. HOWEVER, AFTER REMOVING THE DEVICE FROM THE PATIENT, IT WAS OBSERVED THAT THE DISTAL PORTION OF THE BALLOON BROKE OFF AND WAS NO LONGER ATTACHED TO THE END OF THE DELIVERY SYSTEM. THERE WAS NO EXCESSIVE FORCE APPLIED ON THE DEVICE AND THE END OF THE BALLON REMAINED LODGED IN THE PATIENT. A SNARE DEVICE WAS USED TO ATTEMPT TO RETRIEVE THE DETACHED PORTION BUT WAS UNSUCCESSFUL. THE ACCESS SITE WAS CHANGED T

  Patient problems: Discomfort; Foreign Body In Patient; Heart Block; Reduced Blood Flow; Thrombosis/Thrombus

  MAUDE report 23780816 ↗
• InjuryMar 24, 2025Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE AND DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CALCIFIED CORONARY ARTERY. THE 2.25 X 12 MM NC EMERGE BALLOON WAS SELECTED FOR USE. AFTER SEVERAL INFLATIONS, THE BALLOON RUPTURED AND DURING REMOVAL, BROKE FROM THE SHAFT. A NON-BOSTON SCIENTIFIC HEART PUMP WAS PLACED FOR SUPPORT AND THE PATIENT WAS FLOWN TO ANOTHER FACILITY FOR SURGERY TO REMOVE THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21682356 ↗
• MalfunctionJan 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. A 2.25MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, A LEAK WAS NOTED AND FOUND A PINHOLE IN THE DISTAL TIP. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21276130 ↗
• MalfunctionMay 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.25MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE LESION WAS PRE-TREATED WITH A 2.00MM BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19231864 ↗
• MalfunctionAug 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS PRESENTED WITH CORONARY ARTERY DISEASE AND WAS TO UNDERGO PERCUTANEOUS CORONARY INTERVENTION. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED BUT FAILED TO PASS THE LESION. HOWEVER, DURING THE SECOND INFLATION AT 12 ATMOSPHERES (ATM), THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND ANOTHER 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED, BUT IT ALSO FAILED TO PASS THE LESION AND DURING THIRD INFLATION AT 12 ATM, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND A 1.5X12 NON-BOSTON SCIENTIFIC BALLOON CATHETER WAS PLACED TO TREAT THE LESION. SUBSEQUENTLY, THE PHYSICIAN PROCEEDED TO THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RCA WITH 95% STENOSIS. A 2.25MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING SECOND INFLATION AT 16 ATM, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND DUE TO THE NATURE OF THE PROCEDURE, THE PATIENT WILL BE RETURNING FOR A ROTABLATOR PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17654783 ↗
• MalfunctionJun 30, 2022Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME. A 2.25MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, AS THE PHYSICIAN WAS LOADING THE BALLOON ON THE WIRE, A CHANGE IN ABILITY TO PUSH WAS NOTED WHILE MANEUVERING THE BALLOON IN THE GUIDE. THE DEVICE WAS PULLED BACK AND IT WAS NOTICED THE DEVICE HAD FRACTURED AT THE HYPOTUBE JUNCTION BEFORE ENTERING THE PATIENT'S ANATOMY. ALL OF THE DEVICE WAS PULLED AND REMOVED INTACT FROM THE PATIENT AND A NEW NC EMERGE BALLOON CATHETER WAS USED SUCCESSFULLY. THE PATIENT WAS RECOVERING AND PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14881890 ↗
• InjuryNov 12, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS DISTAL RIGHT CORONARY ARTERY. AFTER A SYNERGY STENT WAS IMPLANTED, A 2.25MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. THE DEVICE DID NOT MOVE AS EXPECTED AND WHEN THE PHYSICIAN REMOVED THE DEVICE, THE DISTAL 30-40CM OF THE DEVICE REMAINED IN THE PATIENT. THE DETACHED SHAFT WAS TRAPPED IN THE GUIDE CATHETER USING ANOTHER BALLOON AND THE ENTIRE SYSTEM WAS SUCCESSFULLY REMOVED FROM THE BODY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10831483 ↗