NC TREK 1012445-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08717648151637), received between Apr 18, 2017 and Jan 13, 2023 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2023Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING DEVICE PREPARATION THE 2.00X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS NOT SOAKED, BUT AIR ASPIRATION WAS PERFORMED. THE PROCEDURE WAS TO TREAT A 90% LESION IN THE LEFT CIRCUMFLEX ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE BDC WAS ADVANCED TO THE TARGET LESION; HOWEVER, DURING THE FIRST INFLATION TO 12 ATMOSPHERES (ATM), THE BALLOON RUPTURED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162735 ↗
• MalfunctionDec 21, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PERIPHERAL PORTION OF A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT SEMI-COMPLIANT BALLOON. THE 2.0X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE WITH THE ANATOMY NOTED AND WAS INTENDED TO PROVIDE ADDITIONAL DILATATION. DURING THE FIRST INFLATION TO 10 ATMOSPHERES, THE PRESSURE OF THE INFLATION DEVICE DECREASED, INDICATING A RUPTURE. THE BALLOON WAS REMOVED AND A RUPTURE WAS NOTED ON THE DISTAL PORTION. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE AND A DRUG COATED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 16024429 ↗
• MalfunctionJan 17, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY THAT IS 90% STENOSED. AN UNSPECIFIED GUIDE WIRE CROSSED AND A 3.5X10MM UNSPECIFIED BALLOON FAILED TO CROSS THE LESION. THE 2.0X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED FOR PRE-DILATATION; HOWEVER, THE BDC RUPTURED AT 12 ATMOSPHERES. IT WAS NOTED DURING ADVANCEMENT RESISTANCE WAS FELT WITH ANATOMY. ANOTHER 3.5X10 UNSPECIFIED BALLOON WAS USED ALONG WITH A 4.0X15MM XIENCE SKYPOINT TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266476 ↗
• MalfunctionAug 17, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING DEVICE PREPARATION OF THE NC TREK BALLOON DILATATION CATHETER, MORE RESISTANCE THAN USUAL WAS FELT DURING ATTEMPTED REMOVAL OF THE PROTECTIVE SHEATH AND STYLET. THE DEVICE WAS NOT USED; 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 12334602 ↗
• MalfunctionMar 5, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT IN JUNE OF 2020, A 2X8MM NC TREK BALLOON DILATATION CATHETER (BDC) FAILED TO INFLATE DURING USE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11423308 ↗
• MalfunctionNov 19, 2020Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY THAT WAS BOTH HEAVILY CALCIFIED AND TORTUOUS AND 90% STENOSED. THE NC TREK BALLOON DILATATION CATHETER MET RESISTANCE DURING ADVANCEMENT TO THE LESION. ONCE AT THE LESION, THE BALLOON WAS INFLATED FIRST TO 14 ATMOSPHERES, THEN TO 16 ATMOSPHERES, BUT RUPTURED. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SINCE THE CALCIFICATION WAS CRACKED, THE PROCEDURE WAS COMPLETED WITH IMPLANTATION OF A STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10871590 ↗
• MalfunctionMar 31, 2020Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE HEAVILY CALCIFIED, MODERATELY TORTUOUS POSTERIOR DESCENDING CORONARY ARTERY. THE 2.00X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE WITH THE ANATOMY NOTED AND INFLATED ONCE TO 18 ATMOSPHERES FOR 10 SECONDS AND RUPTURED DUE TO THE HEAVY CALCIUM. A NON-ABBOTT BDC 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 Consequences Or Impact To Patient

  MAUDE report 9907980 ↗
• MalfunctionMar 10, 2020Difficult to Remove; Material Split, Cut or Torn; Difficult to Remove; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE 2.0X8 MM NC TREK WAS ADVANCED AND SUCCESSFULLY PREDILATED THE BIFURCATION LESION AT THE LEFT CIRCUMFLEX AND OBTUSE MARGINAL CORONARY ARTERY. THE NC TREK WAS DEFLATED WITHOUT ISSUE AND WAS REMOVED FROM THE PATIENT, BUT RESISTANCE WAS MET WITH THE GUIDE WIRE DURING REMOVAL. AT THE END OF THE CASE, IT WAS NOTED THAT THE NC TREK BALLOON HAD TORN, BUT REMAINED ATTACHED. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9812941 ↗
• MalfunctionFeb 26, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 95% STENOSED, DE NOVO LESION IN THE MID-LEFT ANTERIOR DESCENDING ARTERY. A 2.0X8MM RX TREK BALLOON DILATATION CATHETER WAS DELIVERED TO THE TARGET LESION BUT RUPTURED ON THE FIRST INFLATION AT 10 ATMOSPHERES (ATM). THE DEVICE WAS REPLACED WITH A SAME SIZE NON-ABBOTT DEVICE 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 9753603 ↗
• MalfunctionFeb 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF A 2.0X8 NC TREK VOYAGER, THE TIP SEPARATED WHILE REMOVING THE STYLET. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9717410 ↗
• MalfunctionOct 2, 2019Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING PREPARATION, THE SHAFTS OF A 2.0 X 8 MM AND A 3.5 X 12 MM NC TREK BALLOON CATHETER BECAME KINKED. THEREFORE, A NON-ABBOTT BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS REVEALED THAT BOTH DEVICES WERE USED AND THAT THE HYPOTUBES WERE SEPARATED.

  Patient problems: No Patient Involvement

  MAUDE report 9145789 ↗
• MalfunctionSep 19, 2019Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MODERATELY CALCIFIED, NON-TORTUOUS, 90% STENOSED DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. AFTER CROSSING THE LESION, A 2X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED 3 TIMES AT 4 ATMOSPHERES FOR 5 SECONDS EACH. HOWEVER, THE BDC FAILED TO DILATE THE LESION DUE TO THE BALLOON SLIPPING [MOVING]. A NON-ABBOTT BDC 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 9086464 ↗
• MalfunctionAug 20, 2019Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, CHRONICALLY TOTALLY OCCLUDED LESION IN THE HEAVILY TORTUOUS, HEAVILY CALCIFIED, 100% STENOSED MID RIGHT CORONARY ARTERY. ALTHOUGH A NON-ABBOTT GUIDE WIRE CROSSED, A 2 X 12 MM MINI TREK BALLOON DILATATION CATHETER (BDC) FAILED TO CROSS DUE TO THE ANATOMY. HOWEVER, THE BDC WAS INFLATED PROXIMAL TO THE LESION, AND THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 14 ATMOSPHERES (ATMS). THE DEVICE WAS REPLACED WITH A 2 X 8 MM NC TREK BDC, WHICH ALSO FAILED TO CROSS DUE TO THE ANATOMY AND WAS INFLATED PROXIMAL TO THE LESION, BUT THIS BALLOON RUPTURED DURING THE THIRD INFLATION AT 18 ATMS. THE DEVICE WAS REPLACED WITH A NON-ABBOTT BALLOON, BUT THAT DEVICE ALSO RUPTURED. THE PROCEDURE ENDED WITHOUT ANY FURTHER INTERVENTION. 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 8913144 ↗
• MalfunctionJun 13, 2019Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN A MODERATELY TORTUOUS, ECCENTRIC AND MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY THAT WAS 90% STENOSED. PRE-DILATATION WAS PERFORMED WITH A 2.0 X 8 MM NC TREK BALLOON CATHETER; AND IT INITIALLY MET RESISTANCE WITH THE ANATOMY. HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. THEREFORE, THE DEVICE WAS REPLACED WITH A 2.0 X 8 MM NON-ABBOTT BALLOON CATHETER 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 8695709 ↗
• MalfunctionJan 15, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION, A 2.0 X 8 MM NC TREK BALLOON CATHETER WAS ADVANCING THROUGH A TUOHY VALVE. HOWEVER, THE MID SHAFT SEPARATED; THEREFORE, ANOTHER UNSPECIFIED NC TREK BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8248960 ↗
• MalfunctionSep 20, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO, CONCENTRIC LESION IN THE POSTERIOR DESCENDING CORONARY ARTERY WITH NO TORTUOSITY, MODERATE CALCIFICATION AND 90% STENOSIS. A 2.00 X 8 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH NO RESISTANCE; HOWEVER, THE BALLOON RUPTURED ON THE FIRST INFLATION AT 6 ATMOSPHERES. THE BDC WAS SIMPLY REMOVED WITH NO RESISTANCE AND REPLACED WITH AN ADDITIONAL UNSPECIFIED BDC TO CONTINUE THE PROCEDURE. 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 7893594 ↗
• MalfunctionNov 6, 2017Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY PROCEDURE TO TREAT A TARGET LESION IN THE HEAVILY CALCIFIED DIAGONAL ARTERY. THE 2.5 X 20 MM TREK DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION AND WAS INFLATED APPROXIMATELY 4 TIMES. ON THE LAST INFLATION, THE BALLOON RUPTURED AT 18 ATMOSPHERES (ATM). THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND A 2.0 X 8 MM NC TREK DILATATION CATHETER WAS THEN ADVANCED AND INFLATED APPROXIMATELY 4 TIMES. ON THE LAST INFLATION, THE BALLOON RUPTURED AT 18 ATM. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND A 2.75 X 8 MM NC TREK DILATATION CATHETER WAS ADVANCED. THIS DEVICE WAS ALSO INFLATED APPROXIMATELY 4 TIMES AND RUPTURED ON THE LAST INFLATION AT 18 ATM. THE DEVICE WAS REMOVED WITHOUT ISSUE. ADDITIONAL TREK DILATATION CATHETERS WERE USED AND 2 STENTS WERE IMPLANTED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7004125 ↗
• MalfunctionApr 18, 2017Inflation Problem

  IT WAS REPORTED THAT THE 2.0 X 8 MM NC TREK DILATATION CATHETER WAS ADVANCED TO THE TARGET SITE WITHOUT DIFFICULTY AND AN ATTEMPT WAS MADE TO INFLATE THE BALLOON; HOWEVER, THE BALLOON WOULD NOT INFLATE. THE DEVICE WAS REMOVED WITHOUT RESISTANCE AND A SECOND NC TREK DILATATION CATHETER WAS USED WITH THE SAME INFLATION DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6502470 ↗