NC TREK™ 1012450-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648151910), received between Mar 2, 2017 and Jun 1, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2023Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Advance; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN AN UNKNOWN ARTERY. DURING THE PROCEDURE, THERE WAS A KINK NOTICED IN THE SHAFT OF THE 3.25X8MM NC TREK BALLOON DILATATION CATHETER (BDC) PRIOR TO INSERTION INTO THE VESSEL, HOWEVER, THE CATHETER WAS ADVANCED INTO THE ANATOMY. RESISTANCE WAS NOTED DUE TO THE KINK, AND THE SHAFT SEPARATED INSIDE OF THE ANATOMY. ALL OF THE DEVICES WERE REMOVED FROM AS A SINGLE UNIT, AND NOTHING WAS LEFT IN THE PATIENT. A NEW 3.25X8MM NC TREK BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039532 ↗
• MalfunctionAug 20, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN IN-STENT RESTENOSIS IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 3.25X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE WITH THE ANATOMY NOTED. DURING INFLATION TO 12 ATMOSPHERES (ATM) THE INFLATION DEVICE STOPPED INCREASING IN PRESSURE. A LEAK OF CONTRAST WAS NOTED ON CINE AND A BALLOON RUPTURE WAS SUSPECTED. UPON REMOVAL A LEAK WAS NOTED IN THE CENTER OF THE BALLOON. A NEW BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 15262990 ↗
• MalfunctionAug 16, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION THE 3.25X8MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS NOTED TO HAVE THE HUB SNAPPED OFF AT THE END. THE DEVICE WAS IN TWO SEPARATE PIECES. THE DEVICE WAS NOT USED. ANOTHER NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15233953 ↗
• MalfunctionNov 10, 2020Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH MILD CALCIFICATION AND 90% STENOSIS IN THE LEFT CIRCUMFLEX ARTERY. A 3.0X15MM XIENCE PRIME STENT WAS IMPLANTED. A 3.25X8 MM NC TREK DILATATION CATHETER WAS ATTEMPTED FOR POST DILATATION; HOWEVER, FAILED TO CROSS DUE TO THE PATIENT ANATOMY AND THE PROXIMAL SHAFT SEPARATED. THE SEPARATED SHAFT WAS SIMPLY WITHDRAWN FROM THE PATIENT ANATOMY. A NON-ABBOTT BALLOON SUCCESSFULLY CROSSED AND POST DILATATION WAS PERFORMED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10819922 ↗
• MalfunctionJul 17, 2020Device Difficult to Setup or Prepare; Material Rupture; Improper or Incorrect Procedure or Method; Device Difficult to Setup or Prepare; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MODERATELY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY. A 3.25X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPPED WITH DIFFICULTY AND WAS NOT SOAKED PRIOR TO USE. THE BDC WAS ADVANCED WITHOUT RESISTANCE, AND INFLATION WAS INITIATED WHEN A LEAK WAS IMMEDIATELY NOTED FROM THE BALLOON. A NON-ABBOTT BALLOON 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10292439 ↗
• MalfunctionMar 9, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED,MILDLY CALCIFIED, DE NOVO LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY THAT WAS MODERATELY TORTUOUS. AFTER NON-ABBOTT STENT IMPLANTATION, THE NC TREK BALLOON WAS INFLATED TO 10 ATMOSPHERES, BUT RUPTURED. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9808248 ↗
• MalfunctionJan 29, 2019Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY. DURING ADVANCEMENT OF THE 3.25X8 MM NC TREK RX BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS NOTED WITH THE ANATOMY. THE BDC RUPTURED DURING THE FIRST INFLATION AT AROUND 14 ATMOSPHERES. THE BDC WAS REMOVED WITHOUT RESISTANCE AND A 3.25X12 MM NC TREK BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8287626 ↗
• MalfunctionMay 16, 2018Detachment Of Device Component

  IT WAS REPORTED THE 3.25X8MM NC TREK WAS SHEARED OFF. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7520776 ↗
• MalfunctionMar 14, 2018Material Rupture; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED, AND ECCENTRIC LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY THAT WAS 90% STENOSED. AN UNSPECIFIED GUIDE WIRE WAS ADVANCED FOR PRE-DILATATION WITH A 2.5 X 15 MM TREK BALLOON AND THEN A 3.0 X 28 MM XIENCE STENT WAS DEPLOYED. FOR POST-DILATATION, A 3.25 X 8 MM NC TREK BALLOON WAS ADVANCED WITH RESISTANCE DUE TO THE ANATOMY AND RUPTURED DURING THE FIRST INFLATION AT 5 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT BALLOON CATHETER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7339815 ↗
• MalfunctionJun 6, 2017Leak/Splash

  IT WAS REPORTED THAT THE 3.25 X 8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS SUCCESSFULLY PREPPED AND ADVANCED TO THE LESION. DURING INFLATION, A CONTRAST LEAK AROUND THE HUB OF THE CATHETER WAS NOTED. THE BDC WAS REMOVED FROM THE ANATOMY WITHOUT REPORTED ISSUE. 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 6616805 ↗
• MalfunctionMay 26, 2017Inflation Problem; Nonstandard Device

  REPORTEDLY, A 3.25X08MM NC TREK BALLOON DILATATION CATHETER FAILED TO INFLATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6593982 ↗
• MalfunctionMar 2, 2017Difficult to Remove

  IT WAS REPORTED THAT A 3.25 X 8 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS SELECTED FOR THE PROCEDURE. THE MANDREL/STYLET WAS REMOVED AND THE PROTECTIVE SHEATH WAS FLUSHED. RESISTANCE WAS FELT WHILE ATTEMPTING TO REMOVE THE PROTECTIVE SHEATH AND THEY COULD NOT REMOVE IT. THE BDC WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6375110 ↗