NC TREK 1012447-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08717648151774), received between Dec 20, 2017 and Oct 3, 2024 — classified as 3 injuries, 14 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2024Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). FOR PRE-DILATATION, THE 2.5X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY; HOWEVER, WHEN THE BALLOON WAS INFLATED TO NOMINAL PRESSURE, 12 ATMOSPHERES (ATM), THE BALLOON FAILED TO INFLATE. THE PRESSURE WAS INCREASED TO 18 ATM; HOWEVER, THE BALLOON WOULD STILL NOT INFLATE. A THIRD ATTEMPT ALSO FAILED. THE BDC WAS REMOVED FROM THE PATIENT. A 2.25X20MM NC TREK WAS USED TO CONTINUE THE PROCEDURE. IT WAS NOTED THAT PRIOR TO USE, THE DEVICE WAS NOT SOAKED BUT WAS FLUSHED AND WAS NOT PREPPED OUTSIDE THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20363530 ↗
• MalfunctionJul 9, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED A 2.50X20MM RX TREK (LOT 40227G1) WAS INSIDE THE PACKAGING OF THE 2.50X20MM NC TREK BALLOON DILATATION CATHETER (LOT 40212G1). 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 19700095 ↗
• MalfunctionNov 9, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT 2.5X20MM NC TREK BALLOON DILATATION CATHETER WAS NOTE TO HAVE THE CONNECTOR HUB DETACHED FROM THE CATHETER ONCE REMOVED FROM THE PACKAGING. ANOTHER SAME SIZE NC TREK USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 18107935 ↗
• InjuryNov 23, 2022Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 100% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.5X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE FROM THE ANATOMY BUT REACHED THE LESION TO PERFORM DILATATION. DURING REMOVAL, THE BDC MET RESISTANCE FROM THE ANATOMY AND THE BALLOON SEPARATED FROM THE SHAFT. THE BALLOON WAS RETRIEVED FROM THE ANATOMY USING A SNARE. DUE TO HEAVY CALCIUM, THE PHYSICIAN DID NOT COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15859062 ↗
• MalfunctionOct 3, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A BIFURCATION IN THE FIRST DIAGONAL ARTERY. THE 2.5X20MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND FLUSHED PRIOR TO USE BUT WAS DIFFICULT TO ADVANCE TRAPPING THE DISTAL PART OF THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE. THE GUIDE WIRE HAD RESISTANCE UPON REMOVAL WITH THE BALLOON CATHETER AND SOME FORCE WAS APPLIED BREAKING THE PROXIMAL CORE OF THE GUIDE WIRE BUT REMAINING INTACT. THE GUIDE WIRE AND THE BALLOON WERE SIMPLY REMOVED TOGETHER. ANOTHER GUIDE WIRE AND BALLOON WERE USED TO COMPLETE THE PROCEDURE. ANOTHER BALLOON WAS DIFFICULT TO ADVANCE OVER ANOTHER HT BMW UNIVERSAL II GUIDE WIRE IN THE ANTERIOR DESCENDING ARTERY TO PERFORM THE FINAL KISSING BALLOON TECHNIQUE (KBT) REQUIRING THE GUIDE WIRE TO BE CHANGED. THERE WAS NO ADVERSE PATIENT EFFECT 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 15533454 ↗
• MalfunctionDec 22, 2021Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LESION IN THE FIRST OBTUSE MARGINAL (1ST OM) ARTERY. A 2.5X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED ABOVE THE RATED BURST PRESSURE (RBP), TO 28 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. THE BDC WAS SIMPLY REMOVED, AND ANOTHER NC TREK 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 13064726 ↗
• MalfunctionDec 20, 2021Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON THE RIGHT CORONARY ARTERY (RCA), HEAVILY CALCIFIED LESION. AN NC TREK ADVANCED TO THE LESION WITHOUT AN ISSUE NOTED. FOUR INFLATIONS WERE PERFORMED AT 18, 20, 22, AND 26 ATMOSPHERES (ATMS). ON THE FOURTH INFLATION AT 26 ATMS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO OTHER DEVICE ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY ASSOCIATED. ANOTHER DEVICE WAS SUCCESSFULLY USED IN REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13044502 ↗
• MalfunctionDec 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED, MODERATELY TORTUOUS, HEAVILY CALCIFIED, AND CHRONIC TOTALLY OCCLUDED LESION IN THE FIRST AND SECOND DIAGONAL ARTERY AND A 90% STENOSED, HEAVILY TORTUOUS, HEAVILY CALCIFIED, AND CHRONIC TOTALLY OCCLUDED LESION IN THE OBTUSE MARGINAL ARTERY. FOLLOWING THROMBUS ASPIRATION, PRE-DILATATION WAS PERFORMED WITH A 2.5X20MM NC TREK BALLOON DILATATION CATHETER (BDC) AND A 2.5X48MM XIENCE STENT WAS DEPLOYED WITHOUT ISSUES. A 2.5X15MM NC TREK BDC WAS ADVANCED TO THE SECOND DIAGONAL ARTERY AND A 2.5X20MM NC TREK BDC WAS ADVANCED TO THE ANTERIOR DESCENDING ARTERY TO PERFORM KISSING BALLOON ANGIOPLASTY; HOWEVER, THE 2.5X15MM BDC WAS INFLATED TO 12 ATMOSPHERES (ATMS) AND THE BALLOON RUPTURED. THE BDC WAS REMOVED AND NEW UNSPECIFIED DEVICE WAS USED SUCCESSFULLY. A 2.25X15MM BALLOON WAS ADVANCED TO THE FIRST DIAGONAL ARTERY, BUT THE BALLOON RUPTURED WHEN INFLATED TO 12 ATMS. THE BDC WAS REMOVED AND NEW UNSPECIFIED DEVICE WAS USED SUCCESSFULLY. A 2.5X20MM NC TREK BDC WAS ADVANCED TO THE OBTUSE MARGINAL ARTERY AND INFLATED TO 12 ATMS, BUT AGAIN THE BALLOON RUPTURED. THE BDC WAS REMOVED AND A 3.0X20 NON-ABBOTT BALLOON WAS USED SUC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11095613 ↗
• MalfunctionJan 29, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT BEFORE USE AND DURING DEVICE PREPARATION, THE PROTECTIVE SHEATH COULD NOT BE REMOVED FROM THE NC TREK. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9645197 ↗
• InjuryJan 28, 2020Material Separation; Failure to Advance; Difficult to Advance; Material Separation; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED BIFURCATED LEFT ANTERIOR DESCENDING AND DIAGONAL ARTERY. WHILE ADVANCING A 2.5X20 NC TREK BALLOON RESISTANCE WAS MET WITH THE ANATOMY AND 2 UNSPECIFIED GUIDE WIRES. WHEN REMOVING THE DEVICE THE DISTAL SHAFT BECAME SEPARATED AND A SNARE WAS USED TO RETRIEVE IT. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. ANOTHER UNPSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(6) 2020: MEDWATCH REPORT RECEIVED TODAY STATING: [THE SHAFT OF THE INFERIOR BRANCH BALLOON BROKE WITH RETAINED DISTAL SHAFT AND BALLOON IN THE CORONARY ARTERY. THE DISTAL BALLOON CATHETER DEVICE WAS SNARED AND COMPLETELY REMOVED FROM THE BODY.]

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9639956 ↗
• InjuryJan 15, 2020Break

  THE SHAFT OF THE INFERIOR BRANCH BALLOON BROKE WITH RETAINED DISTAL SHAFT AND BALLOON IN THE CORONARY ARTERY. THE DISTAL BALLOON CATHETER DEVICE WAS SNARED AND COMPLETELY REMOVED FROM THE BODY. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9596242 ↗
• MalfunctionOct 2, 2019Difficult to Remove; Material Separation; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Remove; Material Separation; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A 2.75X18MM XIENCE PRO A AND 3.0X26MM NON-ABBOTT STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. POST DILATATION WAS TO BE ATTEMPTED WITH A 2.50X20MM NC TREK BALLOON DILATATION CATHETER (BDC); HOWEVER, HUGE RESISTANCE WAS NOTED DURING ADVANCEMENT DUE TO INTERACTION OF DEVICES. IT WAS NOT CLEAR WHICH STENT THE BDC INTERACTED WITH AS THE STENTS WERE DIRECTLY AFTER EACH OTHER. THE SHAFT KINKED AT TWO POSITIONS. RESISTANCE WITH THE PREVIOUSLY PLACED STENTS OR THE GUIDING CATHETER WAS NOTED DURING WITHDRAWAL. AFTER RETRACTING THE BDC, THE DISTAL SHAFT SEPARATED INTO TWO PIECES OUTSIDE THE ANATOMY, NOTHING REMAINED IN THE ANATOMY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 2.50X20MM NC TREK. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9147846 ↗
• MalfunctionSep 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE ATTEMPT TO ADVANCE THE 2.50 X 20 MM NC TREK BALLOON DILATATION CATHETER (BDC), OVER THE GUIDE WIRE THE SHAFT SEPARATED. THE BDC DID NOT ENTER THE PATIENT ANATOMY. A NEW BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9107571 ↗
• MalfunctionOct 2, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. PRE-DILATATION WAS PERFORMED USING A 1.5MM TREK BALLOON DILATATION CATHETER (BDC). A 2.5X20MM NC TREK BDC WAS THEN ADVANCED WITHOUT RESISTANCE, BUT RUPTURED DURING THE FIRST INFLATION AT 5 ATMOSPHERES. THE 2.5X20MM NC TREK WAS REMOVED WITHOUT RESISTANCE AND THE PROCEDURE CONTINUED WITH A 2.5X15 MM NON-ABBOTT BDC. 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 7926219 ↗
• MalfunctionMay 25, 2018Detachment Of Device Component

  IT WAS REPORTED THAT THE 2.5X20MM NC TREK BALLOON DILATATION CATHETER (BDC) (LOT 80108G1) WAS ADVANCED THROUGH THE COPILOT AND PARTIALLY THROUGH THE GUIDING CATHETER WHEN THE HYPOTUBE SEPARATED. THE SEPARATED PORTION WAS OUTSIDE OF THE PATIENT ANATOMY; THEREFORE THE DISTAL END OF THE SEPARATION WAS SIMPLY PULLED OUT OF THE COPILOT. ANOTHER 2.50X20MM NC TREK (LOT 71026G1) WAS ADVANCED THROUGH THE COPILOT AND THE HYPOTUBE KINKED. THERE WAS NO RESISTANCE REPORTED DURING ADVANCEMENT THROUGH THE COPILOT OR THE GUIDING CATHETER FOR EITHER DEVICE AND NO FORCE WAS APPLIED. THE PROCEDURE WAS COMPLETED AT THIS TIME. 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 7545568 ↗
• MalfunctionJan 11, 2018Detachment Of Device Component; Kinked; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT WHEN REMOVING THE 2.50X20 NC TREK BALLOON DILATATION CATHETER (BDC) FROM THE DISPENSER COIL, THE HYPOTUBE AT THE BASE OF THE HUB WAS NOTED TO BE KINKED. THERE WAS NO DAMAGE NOTED TO THE COIL DISPENSER OR PACKAGING. THE SCRUB TECH ATTEMPTED TO STRAIGHTEN THE SHAFT HOWEVER IT SEPARATED. A NEW DEVICE OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7184498 ↗
• MalfunctionDec 20, 2017Detachment Of Device Component; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED CORONARY ARTERY. DURING ATTEMPTED ADVANCEMENT OF THE 2.5X20 MM NC TREK BALLOON DILATATION CATHETER (BDC) TO THE TARGET LESION; THE DEVICE SEPARATED AT THE MID SHAFT, NEAR THE FIRST SHAFT MARKER. THE SEPARATED SEGMENT WAS REMOVED BY HAND. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7134998 ↗