NC TREK 1012445-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08717648151651), received between Jan 19, 2017 and Jun 26, 2023 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE POSTERIOR LATERAL ARTERY THAT WAS MILDLY TORTUOUS, MILDLY CALCIFIED AND 90% STENOSED. A 2.0X15MM MINI TREK RX BALLOON RUPTURED AT 8 ATMOSPHERES (ATM) DURING THE FIRST INFLATION FOR 10 SECONDS. A 2.0X15MM NC TREK BALLOON WAS USED FOR THE REPLACEMENT, BUT THE BALLOON RUPTURED AT 12 ATM DURING THE FIRST INFLATION FOR 5 SECONDS. A NON-ABBOTT BALLOON WAS USED FOR THE REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 17204011 ↗
• MalfunctionSep 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH TORTUOSITY AND NO CALCIFICATION. THE 2.0X15MM NC TREK RX BALLOON DILATATION CATHETER (BDC) HAD NO RESISTANCE DURING ADVANCEMENT; HOWEVER, THE BALLOON RUPTURED AT AN UNKNOWN PRESSURE DURING FIRST INFLATION. THE BDC WAS SOAKED IN SALINE AND WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. NO RESISTANCE WAS MET WHEN THE PROTECTIVE SHEATH WAS REMOVED. THERE WAS NO RESISTANCE DURING REMOVAL. ANOTHER NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE. 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 15403316 ↗
• MalfunctionJul 20, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 2.0X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) COULD NOT CROSS THE LESION DUE TO THE ANATOMY AND THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL. 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 15067279 ↗
• MalfunctionMar 8, 2022Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. A 2.00 X 15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCE TO THE TARGET LESION; HOWEVER RESISTANCE WAS MET WITH THE ANATOMY. DURING INFLATION THE BALLOON WAS INFLATED THREE TIMES FOR 2-3 SECONDS EACH TIME; HOWEVER THE BALLOON RUPTURED ON THE THIRD INFLATION AT 8 ATMOSPHERES. THE BDC WAS REMOVED FROM THE PATIENT WITH RESISTANCE DUE TO ANATOMICAL CHALLENGES. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13685827 ↗
• MalfunctionSep 23, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 2.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC), SALINE WAS LEAKING FROM THE SHAFT OF THE BDC WHEN FLUSHING. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. 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 12523141 ↗
• MalfunctionSep 21, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. DURING THE PROCEDURE THE 2X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND INFLATED ONE TIME TO 8 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. THE BDC WAS REMOVED AND A PIN-HOLE RUPTURE WAS CONFIRMED. A NEW, SAME SIZED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510790 ↗
• MalfunctionSep 14, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TREATING A TARGET LESION IN THE LEFT CIRCUMFLEX (CX) ARTERY. WHILE ADVANCING THE 2.0 X 15 MM NC TREK THROUGH THE GUIDE CATHETER, IT WAS NOTED THAT THERE WERE TWO ADDITIONAL INTERVENTIONAL WIRES IN THE GUIDE CATHETER, ALONG WITH THE NC TREK. ALTHOUGH NO RESISTANCE WAS NOTED, DURING ADVANCEMENT, THE NC TREK DILATATION CATHETER SEPARATED INTO TWO SEGMENTS, AT THE DISTAL SEGMENT, WHERE THE INFLATION DEVICE ATTACHES. THE SEPARATED SEGMENTS WERE EASILY REMOVED AND A SECOND NC TREK DILATATION CATHETER WAS USED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10530037 ↗
• MalfunctionJun 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 12 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 2.0X15MM NC TREK 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 10121584 ↗
• MalfunctionMay 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED ARTERY. A 2X15MM NC TREK BALLOON BURST DURING USE. 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 10077138 ↗
• MalfunctionMay 4, 2020Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY THAT WAS 99% STENOSED. A 2.0 X 15MM NC TREK BALLOON RUPTURED AT 16 ATMOSPHERES DURING THE SECOND INFLATION. THERE WAS RESISTANCE MET WITH THE LESION DURING ADVANCEMENT. ANOTHER NC TREK WAS USED TO CONTINUE THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED AFTER STENTING WITH A XIENCE SIERRA DEVICE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO SIGNIFICANT DELAY IN THE PROCEDURE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10020429 ↗
• MalfunctionApr 14, 2020Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT A 2.0X12MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED; HOWEVER, THE SHAFT SEPARATED. THE BDC WAS REMOVED. A 2.0X15MM NC TREK RX BDC WAS ADVANCED AND AGAIN THE SHAFT SEPARATED. THE BDC WAS REMOVED. IN BOTH CASES, THE SEPARATIONS MADE IT MORE COMPLEX DURING REMOVAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER UNSPECIFIED BALLOON CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957606 ↗
• MalfunctionOct 15, 2019Material Rupture; Material Separation; Failure to Advance; Material Rupture; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE NC TREK DID NOT CROSS THE CALCIFIED AND MODERATELY TORTUOUS LESION FOR THIS PATIENT, HOWEVER, IT WAS NOT DUE TO PATIENT ANATOMY. THE PATIENT WAS TREATED WITH COMPETITOR DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO OTHER DEVICE ISSUES NOTED. THE PATIENT EXPERIENCED NO UNTOWARD EFFECTS AS A RESULT OF THE FAILURE TO CROSS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS REVEALED A BALLOON RUPTURE AND PROXIMAL SHAFT SEPARATION, HOWEVER, AFTER FOLLOW UP WITH THE CUSTOMER, IT IS NOT KNOWN WHEN THE RUPTURE OF THE BALLOON AND THE PROXIMAL SHAFT SEPARATION OCCURRED. THIS DID NOT OCCUR DURING USE IN THE PATIENT, NOR WAS ANY INJURY TO THE PATIENT REPORTED. THE DEVICE WAS PREPPED WITHOUT ISSUE AND ACCORDING TO THE INSTRUCTIONS FOR USE. THE CORRECT DEVICE WAS RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9194454 ↗
• MalfunctionSep 24, 2019Material 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 LESION LOCATED IN THE MID RIGHT CORONARY ARTERY THAT HEAVILY CALCIFIED AND MODERATELY TORTUOUS. THE NC TREK BALLOON RUPTURED DURING THE SECOND INFLATION AT 22 ATMOSPHERES WHICH IS ABOVE RATED BURST PRESSURE. THERE WAS NO REPORTED RESISTANCE DURING ADVANCEMENT OR RETRACTION. 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 9111569 ↗
• MalfunctionJul 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CONCENTRIC, DE NOVO LESION IN THE MILDLY TORTUOUS, MODERATELY CALCIFIED, 90% STENOSED, DISTAL, RIGHT CORONARY ARTERY WITH A 2.00 X 15 MM NC TREK RX BALLOON DILATATION CATHETER (BDC). THE BDC WAS ADVANCED WITH NO RESISTANCE TO THE LESION AND ON THE FIRST INFLATION TO 6 ATMOSPHERES, FOR 10 SECONDS, THE BALLOON RUPTURED. THE BDC WAS REMOVED FROM THE ANATOMY WITH NO RESISTANCE AND WAS REPLACED WITH A NON-ABBOTT BDC 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 7675997 ↗
• MalfunctionMar 8, 2018Material Rupture; Improper or Incorrect Procedure or Method; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ECCENTRIC DE NOVO LESION IN THE MILDLY TORTUOUS, MODERATELY CALCIFIED, 90% STENOSED POSTERIOR CORONARY ARTERY. A 2.0 X 15 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS INSERTED INTO THE ANATOMY, AIR ASPIRATION WAS PERFORMED, AND THERE WAS NO ISSUE OR LEAK OBSERVED. THE BDC WAS ADVANCED TOWARD THE LESION WITH RESISTANCE, BUT CROSSED THE LESION. ON THE FIRST INFLATION TO 5 ATMOSPHERES, THE BALLOON RUPTURED. THE BDC WAS REMOVED FROM THE ANATOMY WITH NO RESISTANCE FELT. A NEW 2.0 X 15 MM NON-ABBOTT BDC WAS USED TO COMPLETE THE PRE-DILATATION AND THE PROCEDURE WAS COMPLETED WITH THE SUCCESSFUL DEPLOYMENT OF A 2.5 X 20 MM NON-ABBOTT STENT IMPLANT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7324560 ↗
• MalfunctionOct 17, 2017Detachment Of Device Component; Kinked; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE OBTUSE MARGINAL VESSEL WITH MODERATE CALCIFICATION. THE 2.0 X 15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR DILATATION. DURING ADVANCEMENT OF THE NC TREK, RESISTANCE WAS MET WITH THE CALCIFICATION AND THE PROXIMAL SHAFT KINKED, THEN SEPARATED OUTSIDE THE ANATOMY. THIS WAS PRIOR TO REACHING THE LESION. THE NC TREK WAS REMOVED WITHOUT ISSUE AND A NON-ABBOTT BDC WAS USED FOR SUCCESSFUL DILATATION. A 3.0 X 8 MM XIENCE ALPINE STENT WAS SUCCESSFULLY DEPLOYED TO TREAT THE LESION. 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 6955472 ↗
• MalfunctionJun 16, 2017Material Rupture

  SUS VOLUNTARY MEDWATCH REPORT MW5069966 RECEIVED STATING: DURING PROCEDURE, BALLOON RUPTURED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6647063 ↗
• MalfunctionJun 6, 2017Inflation Problem; Material Rupture; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY. A 2.0 X 15 MM NC TREK BALLOON CATHETER WAS BEING ADVANCED TO THE LESION WHEN IT HIT A SHARP PIECE OF CALCIFICATION. WHEN PRESSURIZED, THE BALLOON WOULD NOT INFLATE AND WHEN REMOVED FROM THE ANATOMY THERE WAS A PIN HOLE IN THE BALLOON. ANOTHER NC TREK BALLOON CATHETER WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6615419 ↗
• MalfunctionMay 12, 2017Material Rupture; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CONCENTRIC LESION LOCATED IN THE CIRCUMFLEX ARTERY THAT WAS HEAVILY TORTUOUS, HEAVILY CALCIFIED AND 99% STENOSED. THE NC TREK RX 2.0 X 15 MM BALLOON DILATATION CATHETER WAS BEING USED FOR PRE-DILATATION, WHEN THE BALLOON RUPTURED DURING FIRST INFLATION AT AN UNKNOWN PRESSURE. THERE WAS RESISTANCE REPORTED WITH THE ANATOMY DURING ADVANCEMENT. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE WITH NO ISSUES OR LEAKS NOTED DURING PREPARATION. THERE WAS NO RESISTANCE DURING REMOVAL OF THE PROTECTIVE SHEATH. THE DEVICE WAS REPLACED WITH A NON-ABBOTT BALLOON TO COMPLETE THE PROCEDURE. 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 6565242 ↗
• MalfunctionJan 19, 2017Material Rupture; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, MILDLY TORTUOUS, AND HEAVILY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 2.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER, SLIGHT RESISTANCE WAS FELT WITH THE ANATOMY WHILE ADVANCING. THE BALLOON RUPTURED DURING FIRST INFLATION AT 10 ATMOSPHERES FOR 5 SECONDS. THE BDC WAS REMOVED AND REPLACED WITH A NON-ABBOTT BDC. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE STENT IMPLANTATION OF A 2.5X28MM XIENCE ALPINE STRNT. 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 6265011 ↗