NC TREK™ 1012452-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08717648152016), received between Aug 24, 2016 and Dec 6, 2022 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (12 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 3.75X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) FAILED TO CROSS THE LESION DUE TO THE ANATOMY AND THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL. A NON-ABBOTT BDC WAS USED TO COMPLETE 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 15928874 ↗
• MalfunctionJun 28, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED, MODERATELY TORTUOUS AND 95% STENOSED. RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE 3.75X8MM NC TREK TO THE LESION. DURING THE FIRST INFLATION TO NOMINAL PRESSURE, THE BALLOON RUPTURED BECAUSE OF THE CALCIFIED LESION. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. ULTIMATELY, A STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14848791 ↗
• MalfunctionAug 20, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 75% STENOSED LESION IN THE FIRST OBTUSE MARGINAL (OM1) ARTERY. A 3.75X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED BUT DUE TO RESISTANCE FROM THE ANATOMY, DID NOT REACH THE TARGET LESION. RESISTANCE WAS NOTED DURING REMOVAL. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. TREATMENT WITH ROTABLATION IS SCHEDULED FOR A LATER DATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12351486 ↗
• MalfunctionJun 2, 2021Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. DURING ADVANCEMENT OF THE 3.75X8MM NC TREK RESISTANCE WAS MET WITH ANATOMY. BALLOON DILATATION WAS ATTEMPTED; HOWEVER, THE BALLOON RUPTURED AT THE FIRST INFLATION. ANOTHER UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11922410 ↗
• MalfunctionJul 15, 2020Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED, MODERATELY TORTUOUS, MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 3.75X8MM NC TREK BALLOON BALLOON DILATATION CATHETER (BDC) FACED RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT, AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. 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 10276153 ↗
• MalfunctionFeb 11, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY THAT WAS 90% STENOSED. THE 3.75X8NN NC TREK BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THE DEVICE WAS REPLACED WITH A NON-ABBOTT BALLOON 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 9696400 ↗
• MalfunctionJan 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY IN RIGHT CORONARY ARTERY (RCA). A NON-ABBOTT STENT WAS IMPLANTED. POST DILATATION WAS PERFORMED USING A 3.75 X 8 MM NC TREK BALLOON, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9591538 ↗
• MalfunctionDec 19, 2019Material Rupture; Material Rupture

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, THE CORRECT SIZE OF THE NC TREK BALLOON IS A 3.5 X 8 MM, PART NUMBER 1012451-08. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492880 ↗
• MalfunctionMar 29, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT A CONCENTRIC LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY THAT WAS NON-TORTUOUS, HEAVILY CALCIFIED AND 90% STENOSED, THE NC TREK RX BALLOON RUPTURED WHEN THE BALLOON WAS SLOWLY INFLATED TO 6 ATMOSPHERES. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8467219 ↗
• MalfunctionOct 31, 2018Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, ECCENTRIC LESION IN THE HEAVILY TORTUOUS, PROXIMAL RIGHT CORONARY ARTERY. A 2.75X15 MM XIENCE SIERRA STENT WAS IMPLANTED AND AFTER CONFIRMATION WITH INTRAVASCULAR ULTRASOUND (IVUS), THE STENT WAS FOUND TO BE MAL-APPOSED. THERE WERE NO OTHER ISSUES NOTED WITH THE XIENCE SIERRA STENT. A 3.75X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION; HOWEVER, THE BDC COULD NOT CROSS THE LESION DUE TO RESISTANCE WITH THE LESION. RESISTANCE WAS FELT WITH THE LESION DURING REMOVAL OF THE BDC. NO DAMAGE WAS NOTED TO THE NC TREK BDC. A NON-ABBOTT BDC WAS USED TO COMPLETE THE PROCEDURE AND THE XIENCE SIERRA WAS FULLY APPOSED TO THE VESSEL WALL. NO DAMAGE WAS NOTED TO THE STENT IMPLANT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8026679 ↗
• MalfunctionJun 27, 2018Detachment Of Device Component; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING DEVICE UNPACKING AND PRIOR TO USE, THE 3.75 X 8 MM NC TREK PLASTIC HOLDER WAS NOTED TO BE KINKED. WHILE ATTEMPTING TO REMOVE THE DEVICE FROM THE HOLDER, THE HUB DETACHED FROM THE CATHETER SHAFT. THERE WAS NO DAMAGE NOTED TO THE OUTER CHIPBOARD BOX. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7643664 ↗
• MalfunctionMay 7, 2018Deflation Problem; Folded

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE CIRCUMFLEX. A 3.75X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS BEING USED TO POST-DILATE A DEPLOYED NON-ABBOTT STENT. THE CONTRAST MIX WAS 50:50 AND THE BALLOON WAS INFLATED 2 TIMES AT 14 ATMOSPHERES. DIFFICULTY DEFLATING THE BALLOON WAS NOTED AND THE BALLOON PROLAPSED ON THE PROXIMAL END WHEN IT WAS DEFLATED. THE BDC WAS REMOVED WITH THE BALLOON DEFLATED. 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 7492041 ↗
• MalfunctionMay 4, 2018Inflation Problem; Stretched

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE MODERATELY CALCIFIED, PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 3.75X08 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT ISSUE IN THE PATIENT ANATOMY. HOWEVER, THE BALLOON COMPLETELY FAILED TO INFLATE. THE BDC WAS REMOVED FROM THE PATIENT ANATOMY WITHOUT ISSUE AND A SAME SIZE NC TREK WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THE PROXIMAL SEAL WAS STRETCHED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7487644 ↗
• MalfunctionMar 22, 2017Difficult to Remove

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE PROTECTIVE SHEATH WAS DIFFICULT TO REMOVE FROM THE 3.75X8 NC TREK. THE DEVICE WAS INFLATED AND DEFLATED OUTSIDE THE ANATOMY AND WORKED WITHOUT ISSUE, SO THE DEVICE WAS USED IN THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS DEVICE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6426418 ↗
• MalfunctionMar 16, 2017Difficult to Remove; Torn Material

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE 3.75 X 8 MM NC TREK DILATATION CATHETER PROTECTIVE SHEATH WAS UNABLE TO BE REMOVED. A SYRINGE WAS USED TO FLUSH THE SHEATH, IN THE HOPES THAT IT WOULD LOOSEN TO BE REMOVED. THE PHYSICIAN PULLED HARD ON THE SHEATH AND WAS ABLE TO REMOVE IT; HOWEVER, A TEAR IN THE BALLOON OCCURRED. THE DEVICE WAS NOT USED AND A 3.75 X 8 MM NON-ABBOTT DILATATION CATHETER WAS USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6411989 ↗
• MalfunctionFeb 8, 2017Break; Kinked; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING PREPARATION A 3.75 X 8 MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS REMOVED WITHOUT RESISTANCE FROM THE DISPENSER COIL AND A KINK WAS NOTED IN THE SHAFT. THE PHYSICIAN ATTEMPTED TO STRAIGHTEN THE CATHETER. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE REVEALED THE PROXIMAL BALLOON MARKER WAS SEPARATED.

  Patient problems: No Patient Involvement

  MAUDE report 6311898 ↗
• MalfunctionJan 9, 2017Deflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY. A 3.75X8MM NC TREK RX BALLOON DILATATION CATHETER (BDC) STYLET/PROTECTIVE SHEATH WAS REMOVED WITHOUT RESISTANCE. THE BDC WAS NOT PREPPED OUTSIDE THE ANATOMY PRIOR TO USE. THE BDC WAS ADVANCED TO PERFORM POST DILATATION, THE BALLOON WAS INFLATED ONCE UP TO 14 ATMOSPHERES AND THE LESION WAS TREATED. AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON AND THE BALLOON WOULD NOT DEFLATE. REPORTEDLY IT TOOK 2 MINUTES FOR THE BALLOON TO COMPLETELY DEFLATE. ULTIMATELY THE BDC WAS REMOVED FULLY DEFLATED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6233424 ↗
• MalfunctionDec 15, 2016Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MODERATELY TORTUOUS, MODERATELY CALCIFIED DE NOVO CIRCUMFLEX CORONARY ARTERY. THE 3.75X08 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED IN THE PATIENT ANATOMY; HOWEVER, THE BALLOON FAILED TO INFLATE. THE NC TREK RX BDC WAS REMOVED AND ANOTHER NC TREK RX BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6178512 ↗
• MalfunctionNov 10, 2016Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MILDLY TORTUOUS, MILDLY CALCIFIED, MID LEFT ANTERIOR DESCENDING ARTERY. AFTER ONE INFLATION OF THE 3.75 X 8 MM NC TREK BALLOON TO 18 ATMOSPHERES SUCCESSFULLY FOR PREDILATATION OF THE LESION, THE BALLOON COULD NOT BE DEFLATED AT ALL AND WAS REMOVED USING FORCE, WHILE STILL INFLATED. THE CONTRAST RATIO USED WAS 60% SALINE AND 40% CONTRAST. 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 6094119 ↗
• MalfunctionOct 31, 2016Difficult to Remove

  AN UNUSED/STERILE 3.75 X 8 MM NC TREK BALLOON DILATATION CATHETER WAS RETURNED RELATED TO A CASE WHICH HAD REPORTED RESISTANCE REMOVING THE PROTECTIVE SHEATH. RETURNED DEVICE ANALYSIS CONFIRMED RESISTANCE DURING REMOVAL OF THE PROTECTIVE SHEATH FROM THIS DEVICE. THE PROTECTIVE SHEATH COULD NOT BE REMOVED.

  Patient problems: No Patient Involvement

  MAUDE report 6068425 ↗
• MalfunctionOct 31, 2016Difficult to Remove

  AN UNUSED/STERILE 3.75 X 8 MM NC TREK BALLOON DILATATION CATHETER WAS RETURNED RELATED TO A CASE WHICH HAD REPORTED RESISTANCE REMOVING THE PROTECTIVE SHEATH. RETURNED DEVICE ANALYSIS CONFIRMED RESISTANCE DURING REMOVAL OF THE PROTECTIVE SHEATH FROM THIS DEVICE. THE PROTECTIVE SHEATH COULD NOT BE REMOVED.

  Patient problems: No Patient Involvement

  MAUDE report 6068422 ↗
• MalfunctionOct 31, 2016Difficult to Remove

  AN UNUSED/STERILE 3.75 X 8 MM NC TREK BALLOON DILATATION CATHETER WAS RETURNED RELATED TO A CASE WHICH HAD REPORTED RESISTANCE REMOVING THE PROTECTIVE SHEATH. RETURNED DEVICE ANALYSIS CONFIRMED RESISTANCE DURING REMOVAL OF THE PROTECTIVE SHEATH FROM THIS DEVICE. THE PROTECTIVE SHEATH COULD NOT BE REMOVED.

  Patient problems: No Patient Involvement

  MAUDE report 6068421 ↗
• MalfunctionOct 26, 2016Difficult to Remove

  AN UNUSED/STERILE 3.75 X 8 MM NC TREK BALLOON DILATATION CATHETER WAS RETURNED RELATED TO A CASE WHICH HAD REPORTED RESISTANCE REMOVING THE PROTECTIVE SHEATH. RETURNED DEVICE ANALYSIS CONFIRMED RESISTANCE DURING REMOVAL OF THE PROTECTIVE SHEATH FROM THIS DEVICE. THE PROTECTIVE SHEATH COULD NOT BE REMOVED.

  Patient problems: No Patient Involvement

  MAUDE report 6057759 ↗
• MalfunctionOct 26, 2016Difficult to Remove

  AN UNUSED/STERILE 3.75 X 8 MM NC TREK BALLOON DILATATION CATHETER WAS RETURNED RELATED TO A CASE WHICH HAD REPORTED RESISTANCE REMOVING THE PROTECTIVE SHEATH. RETURNED DEVICE ANALYSIS CONFIRMED RESISTANCE DURING REMOVAL OF THE PROTECTIVE SHEATH FROM THIS DEVICE. THE PROTECTIVE SHEATH COULD NOT BE REMOVED.

  Patient problems: No Patient Involvement

  MAUDE report 6057756 ↗
• MalfunctionSep 13, 2016Inflation Problem; Difficult to Remove

  IT WAS REPORTED THE PROTECTIVE SHEATH WAS VERY HARD TO REMOVE FROM THE NC TREK BALLOONS. THE 3.75 X 8 MM NC TREK WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON DID NOT INFLATE DESPITE THE INDEFLATOR SHOWING PRESSURE. THE DEVICE WAS WITHDRAWN AND OUTSIDE THE PATIENT ANATOMY, THE BALLOON WAS ABLE TO INFLATE TO HIGH PRESSURE. THE 3.75 X 12 MM NC TREK BALLOON SEPARATED COMPLETELY DURING THE ATTEMPT TO REMOVE THE STYLET. OTHER DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5948049 ↗