NC TREK 1012452-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648152047), received between Aug 4, 2016 and Dec 11, 2023 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA) WITH STENOSIS. THE 3.75X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION AND INFLATED TWO TIMES, HOWEVER, DURING THE SECOND INFLATION, THE BALLOON DID NOT MAINTAIN PRESSURE. FIRST ASSUMPTION WAS THAT THE BALLOON HAD BURST BUT THERE WAS NO VISIBLE LEAKAGE FROM THE BALLOON. UPON REMOVAL WITHOUT RESISTANCE, ONLY THE PROXIMAL SHAFT WAS RETRIEVED. WITH THE HELP OF AN ADDITIONAL WIRE, THE SEPARATED PORTION OF THE SHAFT WAS ABLE TO BE PULLED BACK INTO THE CATHETER AND REMOVED THE ENTIRE SYSTEM. ANOTHER NC TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELAE AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18306471 ↗
• MalfunctionJan 26, 2023Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH 70% STENOSIS. AFTER OPENING THE 3.75X20 MM NC TREK BALLOON DILATATION CATHETER (BDC), THE YELLOW PROTECTIVE SHEATH WAS ATTEMPTED TO BE REMOVED, BUT IT COULD NOT BE REMOVED. THEREFORE, THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NON-ABBOTT BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16248151 ↗
• MalfunctionFeb 18, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE DURING PREPARATION OF A 3.75X20MM NC TREK BALLOON DILATATION CATHETER (BDC), THE PROTECTIVE SHEATH COULD NOT BE REMOVED FROM THE BDC. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11346951 ↗
• MalfunctionOct 14, 2020Deflation Problem; Failure to Fold; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Failure to Fold; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING PREPARATION OF THE 3.75X20MM NC TREK BALLOON DILATATION CATHETER (BDC), DIFFICULTY WAS EXPERIENCED IN REMOVING THE PROTECTIVE SHEATH. THE BDC WAS ADVANCED TO THE 70% STENOSED MID TO PROXIMAL RIGHT CORONARY ARTERY (RCA) FOR POST-DILATATION. THE BDC WAS INFLATED 3 TIMES TO 20 KILOPASCAL-PRESSURE-UNITS (KPA), AND NEGATIVE WAS HELD FOR 5 SECONDS, BUT THE BALLOON WOULD NOT FULLY DEFLATE, OR REFOLD TIGHTLY ENOUGH TO BE PULLED BACK INTO THE GUIDING CATHETER, SO THE GUIDE WIRE, GUIDE CATHETER, AND PARTIALLY DEFLATED BALLOON WERE REMOVED AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT, OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10680821 ↗
• MalfunctionApr 29, 2020Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT PRIOR TO USE, A 3.75X20MM NC TREK BALLOON DILATATION CATHETER (BDC) MATERIAL APPEARED TO BE WRINKLED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW SAME SIZE NC TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE INNER MEMBER OF THE SHAFT WAS NOTED TO BE SEPARATED, BUT THE OUTER MEMBER REMAINED INTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10010144 ↗
• InjuryDec 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 3.75X20MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS BEING USED TO POST-DILATE A 3.5MM NON-ABBOTT STENT; HOWEVER, THE BALLOON RUPTURED AT ABOUT 4-6 ATMOSPHERES. SEVERAL SMALL AIR BUBBLES ESCAPED INTO THE VESSEL. THE PATIENT THEN EXPERIENCED VENTRICULAR TACHYCARDIA (NOT-SUSTAINED OR REQUIRING SHOCK) AND IT RESOLVED QUICKLY. THE BALLOON WAS REMOVED INTACT WITHOUT FURTHER INCIDENT. THE PROCEDURE WAS COMPLETED WITH SUCCESSFUL POST-DILATATION OF THE STENT WITH A NEW 3.75X20MM NC TREK BDC. THE PATIENT IS FINE AND WELL TODAY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Air Embolism; Ventricular Tachycardia

  MAUDE report 9411439 ↗
• MalfunctionAug 19, 2019Inflation Problem; Leak/Splash; Difficult to Remove; Material Separation; Inflation Problem; Leak/Splash; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI) TREATING A PROXIMAL LEFT ANTERIOR DESCENDING (LAD) LESION. FOR POST-DILATATION, AN NC TREK ADVANCED OVER A RUN THROUGH WIRE AND TO A PREVIOUSLY IMPLANTED, UNSPECIFIED STENT WITHOUT ISSUES. BALLOON INFLATION WAS ATTEMPTED, HOWEVER, FAILED AND BLOOD WAS NOTED IN THE DEVICE AND CONTRAST IN THE VESSEL. IT WAS DECIDED TO REMOVE THE NC TREK. DURING REMOVAL, RESISTANCE WAS FELT AT THE COPILOT SITE AND THE SHAFT HAD THEN SEPARATED APPROXIMATELY 25 CM FROM THE TIP. THE DEVICE WAS REMOVED WITHOUT FURTHER ISSUES. ONCE OUTSIDE THE ANATOMY, THE BALLOON APPEARED FINE, WITHOUT ANY MATERIAL SEPARATION NOTED. THE REST OF THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES AND WITH THE SAME COPILOT DEVICE. REPORTEDLY, THERE WAS NO ISSUE WITH THE COPILOT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8907653 ↗
• MalfunctionAug 8, 2018Material Separation; Failure to Advance; Deformation Due to Compressive Stress; Material Separation; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED, LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 3.75X20 MM NC TREK BALLOON DILATATION CATHETER (BDC) FAILED TO CROSS THE TARGET LESION DUE TO THE ANATOMY, THE PROXIMAL SHAFT KINKED AND SEPARATED AT THE PROXIMAL SHAFT. THE SEPARATED PORTION WAS SIMPLY WITHDRAWN. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. AN UNSPECIFIED BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7764185 ↗
• MalfunctionOct 25, 2017Difficult to Remove; Improper or Incorrect Procedure or Method; Folded

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SAPHENOUS VEIN GRAFT TO THE DIAGONAL. THE 2.0 X 15 MM MINI TREK BALLOON CATHETER WAS USED FOR TREATMENT OF A LESION IN THE MID DIAGONAL ARTERY. THE 3.75 X 20 MM NC TREK BALLOON CATHETER WAS USED FOR TREATMENT OF A DE NOVO LESION LOCATED IN THE MODERATELY TORTUOUS, DISTAL DIAGONAL ARTERY AND WAS INFLATED TO 20 ATMOSPHERES. THERE WAS NO DIFFICULTY EXPERIENCED DURING DEFLATION OF THE BALLOONS; HOWEVER, DURING RETRACTION AFTER USE, BOTH BALLOONS MET RESISTANCE DURING REMOVAL THROUGH THE Y CONNECTOR; HOWEVER, WERE ABLE TO BE SUCCESSFULLY REMOVED. THE BALLOONS APPEARED TO BE "BUNCHED UP";.BOTH BALLOONS WERE CONFIRMED TO BE FULLY DEFLATED PRIOR TO REMOVAL THROUGH THE Y-CONNECTOR. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6978373 ↗
• MalfunctionJun 15, 2017Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS NON-CALCIFIED AND NON-TORTUOUS. THE NC TREK 3.75 X 20 MM BALLOON DILATATION CATHETER WAS BEING USED FOR POST DILATATION, BUT COMPLETELY FAILED TO INFLATE. THE DEVICE WAS REMOVED FROM THE ANATOMY AND ANOTHER SAME SIZE NC TREK WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE AND THERE WAS NO RESISTANCE DURING REMOVAL OF THE PROTECTIVE SHEATH. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6644633 ↗
• MalfunctionMar 2, 2017Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION. A 3.75 X 20 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION FOR POST-DILATATION AND IT CROSSED SUCCESSFULLY. THE NC TREK WAS INFLATED ONCE TO AN UNKNOWN PRESSURE; HOWEVER, IT WOULD NOT DEFLATE USING THE INDEFLATOR. A 30 CC SYRINGE WAS USED TO PULL NEGATIVE PRESSURE SEVERAL TIMES AND THE BALLOON FINALLY DEFLATED COMPLETELY. THE BDC WAS REMOVED FROM THE ANATOMY WITHOUT RESISTANCE. A NEW NC BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6374757 ↗
• MalfunctionFeb 27, 2017Inflation Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE, THE NC TREK DILATATION CATHETER BALLOON WOULD NOT INFLATE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. A SECOND NC TREK WAS USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6363323 ↗
• MalfunctionAug 4, 2016Inflation Problem

  IT WAS REPORTED THAT THE 3.75X20MM NC TREK ADVANCED TO THE MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION WITHOUT ISSUE. DURING BALLOON INFLATION ATTEMPT, THE BALLOON FAILED TO INFLATE. THE DEVICE WAS REMOVED WITHOUT ISSUE AND ANOTHER DEVICE WAS USED IN REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5848630 ↗