NC TREK 1012448-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08717648151835), received between Aug 30, 2016 and Oct 2, 2023 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2023Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THE 2.75X20 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS NOTED TO HAVE RUPTURED AT NOMINAL PRESSURE, AS WHEN PRESSURE WAS INCREASED, THE CONTRAST WENT INTO THE ARTERY. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW SIMILAR BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17856933 ↗
• MalfunctionApr 17, 2023Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT TO A RIGHT CORONARY ARTERY. THE 2.75X20MM NC TREK BALLOON DILATATION CATHETER WAS ADVANCING THROUGH AN UNSPECIFIED GUIDE CATHETER; HOWEVER THE SHAFT OF THE NC TREK SEPARATED AS RESISTANCE WITH THE UNSPECIFIED GUIDE CATHETER WAS NOTED. THE DEVICE WAS SEPARATED PORTION WAS SIMPLY WITHDRAWN AS PART OF THE DEVICE WAS STICKING OUT OF THE GUIDE. A 2.75X20MM NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16753471 ↗
• MalfunctionOct 11, 2022Difficult 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 LESION IN THE RIGHT CORONARY ARTERY (RCA). A 2.75X20MM NC TREK BALLOON DILATATION CATHETER (BDC) FAILED TO CROSS THE ANATOMY AND WAS NOT IMPLANTED. THE BDC WAS REMOVED WITH RESISTANCE MET FROM THE ANATOMY AND A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15577647 ↗
• MalfunctionSep 30, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS UNKNOWN CORONARY ARTERY. THE 2.75X20MM NC TREK BALLOON DILATATION CATHETER WAS ADVANCED. HOWEVER; MET RESISTANCE WITH THE LESION. DURING THE FIRST INFLATION THE BALLOON RUPTURED 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 REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15514126 ↗
• MalfunctionJul 26, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 2.75X20 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. ANOTHER, SAME SIZE NC TREK 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 15106079 ↗
• MalfunctionOct 22, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS, DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.75X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED ONE TIME TO 14 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. A SMALL HOLE WAS OBSERVED ON THE MID PART OF THE BALLOON. ANOTHER NC TREK 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12684619 ↗
• MalfunctionJun 28, 2019Inflation Problem; Difficult to Remove; Material Rupture; Material Separation; Difficult to Advance; Inflation Problem; Difficult to Remove; Material Rupture; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. A 6F SHEATH WAS PLACED AND TWO UNSPECIFIED GUIDE WIRES AND A NON- ABBOTT GUIDE CATHETER EXTENSION WERE ADVANCED. A 2.75 X 20 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS THEN ADVANCED THROUGH THE SHEATH WITH RESISTANCE FROM ALL OTHER DEVICES DUE TO THE TIGHT FIT. ON ATTEMPTING TO INFLATE THE BALLOON OF THE BDC TO 16 ATMOSPHERES, THE BALLOON FAILED TO INFLATE. THE BDC FAILED TO HOLD PRESSURE AND BLOOD WAS NOTED TO BE BACKING UP INTO THE MANIFOLD [RUPTURE]. THE BDC WAS THEREFORE ATTEMPTED TO BE REMOVED WITHOUT FORCE; HOWEVER, RESISTANCE WAS MET WITH THE SHEATH ON REMOVAL AND A DISTAL SHAFT SEPARATION OCCURRED. THE SEPARATED PORTION OF THE BDC WAS SIMPLY REMOVED ON THE GUIDE WIRE AND A NEW 2.75 X 20 NC TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746349 ↗
• MalfunctionJun 13, 2019Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING ADVANCEMENT OF THE 2.75X20 MM NC TREK BALLOON DILATATION CATHETER (BDC) INTO THE GUIDING CATHETER, THE PHYSICIAN STATED HE WAS TOO ROUGH WITH THE BDC OUTSIDE THE GUIDE CATHETER AND THE SHAFT KINKED. IT WAS ATTEMPTED TO STRAIGHTEN THE SHAFT OF THE BDC, BUT DURING REINSERTION INTO THE GUIDING CATHETER THE PROXIMAL SHAFT SEPARATED. THE DISTAL SEPARATED PORTION OF THE BDC WAS REMOVED INSIDE THE GUIDING CATHETER. A NEW NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE WITH THE SAME GUIDING CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8696063 ↗
• MalfunctionNov 14, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED, MODERATELY CALCIFIED, DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 2.75X20MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION, WITHOUT RESISTANCE, TO PERFORM DILATATION; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THE BDC WAS REMOVED WITHOUT RESISTANCE AND REPLACED WITH A NON-ABBOTT BDC TO PERFORM DILATATION. A NON-ABBOTT STENT WAS DEPLOYED IN THE TARGET LESION TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8071847 ↗
• MalfunctionMar 28, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT RESTENOSIS INSIDE AN OLD STENT LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MILDLY TORTUOUS, MODERATELY CALCIFIED AND 95% STENOSED. LASER ATHERECTOMY WAS PERFORMED FOLLOWED BY BALLOON DILATATION USING THE NC TREK 2.75 X 15 MM BALLOON DILATATION CATHETER. THEN, THE 2.75 X 20 MM NC TREK WAS INFLATED AT 11 ATMOSPHERES FOR ONE MINUTE. THE SECOND INFLATION WAS AT 11 ATMOSPHERES FOR ONE MINUTE. THE THIRD INFLATION WAS AT 14 ATMOSPHERES FOR ONE MINUTE. DURING THE FOURTH INFLATION, AT 18 ATMOSPHERES THE BALLOON BURST AT 45 SECONDS. THERE WAS NO RESISTANCE DURING ADVANCEMENT AND THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WERE NO REPORTED 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 7379985 ↗
• MalfunctionDec 5, 2017Difficult to Remove; Stretched

  IT WAS REPORTED THAT DURING REMOVAL OF THE PROTECTIVE SHEATH FROM THE 2.75 X 20 MM NC TREK BALLOON CATHETER, RESISTANCE WAS FELT WHICH LED TO STRETCHING OF THE BALLOON. THE DEVICE COULD NOT BE USED ON THE PATIENT. A NEW BALLOON CATHETER WAS USED SUCCESSFULLY FOR THE CASE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7084211 ↗
• MalfunctionJun 20, 2017Detachment Of Device Component; Insufficient Device Problem Information

  REPORTEDLY, THERE WAS AN ISSUE WITH THREE NC TREK BALLOON DILATATION CATHETERS; HOWEVER, THERE WAS NO INFORMATION AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE RETURN DEVICE ANALYSIS OF THE THREE NC TREK CATHETERS FOUND THE FOLLOWING: THE 3.5X8MM NC TREK: THE OUTER MEMBER WAS STRETCHED AND TORN AT THE PROXIMAL SEAL. THE 3.75X12MM NC TREK: THE OUTER MEMBER WAS STRETCHED AT THE PROXIMAL SEAL. THE 2.75X20MM NC TREK: THE HYPOTUBE WAS SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6654847 ↗
• MalfunctionDec 19, 2016Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT PRIOR TO USE, DURING DEVICE PREPARATION, THE PROTECTIVE SHEATH OF THE NC TREK BALLOON MET RESISTANCE DURING REMOVAL. ADDITIONALLY, THE DEVICE WAS NOT SUBMERGED IN STERILE HEPARINIZED NORMAL SALINE TO ACTIVATE THE COATING; HOWEVER, THE DEVICE WAS SUCCESSFULLY USED IN THE PATIENT WITHOUT REPORTED ISSUE. THIS OCCURRED WITH 4 SEPARATE DEVICES. 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 6187880 ↗
• MalfunctionNov 14, 2016Difficult to Remove

  IT WAS REPORTED THAT DURING DEVICE PREPARATION AND PRIOR TO USE IN THE PATIENT THE NC TREK BALLOON PROTECTIVE SHEATH WAS DIFFICULT TO REMOVE. THE DEVICE WAS NOT USED; THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6099837 ↗
• MalfunctionNov 4, 2016Detachment Of Device Component

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE 2.75X20 MM NC TREK RX BALLOON DILATATION CATHETER WAS REMOVED WITHOUT RESISTANCE FROM THE HOOP, AND THE MID-SHAFT SEPARATED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE INTENDED PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6080584 ↗
• MalfunctionAug 30, 2016Inflation Problem; Difficult to Remove

  IT WAS REPORTED THAT PRIOR TO USE, THE PROTECTIVE SHEATH WAS ABLE TO BE REMOVED FROM THE NC TREK, BUT WITH RESISTANCE. THE NC TREK WAS INSERTED TO POST DILATE A 2.75X38 XIENCE ALPINE STENT IN THE 99% STENOSED, HEAVILY CALCIFIED LESION IN THE LEFT CIRCUMFLEX CORONARY ARTERY. THE NC TREK REACHED THE LESION, BUT WOULD NOT INFLATE WHEN THE INFLATION DEVICE WAS TAKEN TO 10 ATMOSPHERES. THE NC TREK WAS REMOVED FROM THE ANATOMY AND TESTED BY THE DOCTOR ON THE BACK TABLE. THE DOCTOR NOTED THAT THE NC TREK BEGAN TO INFLATE AFTER THE INFLATION DEVICE WAS TAKEN TO 10 ATMOSPHERES. ANOTHER NC TREK WAS SUCCESSFULLY USED TO 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 5914648 ↗