NC TREK™ 1012455-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08717648152160), received between Feb 7, 2018 and May 3, 2024 — classified as 1 death, 6 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (14 reports).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 29, 2020Terminated

   Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

   Z-1139-2020 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. AFTER INFLATING AND POST DILATATION OF THE UNSPECIFIED STENT, WHEN ATTEMPTING TO REMOVE THE FULLY DEFLATED 5.0X20MM NC TREK BALLOON DILATATION CATHETER (BDC) THE BDC PROXIMAL SHAFT SEPARATED IN THE 6F GUIDE CATHETER LEAVING THE SEPARATED PORTION IN THE GUIDE CATHETER. AS THE BDC WAS STILL OUT OF THE UNSPECIFIED INTRODUCER SHEATH FORCEPS WERE USED TO REMOVE IT FROM THE GUIDE CATHETER. FURTHERMORE, WHEN ATTEMPTING TO REMOVE THE BDC FROM THE GUIDE INTO THE INTRODUCER THE BDC SHAFT SEPARATED AGAIN LEAVING THE SEPARATED PORTION IN THE INTRODUCER. THE SEPARATED PORTIONS WERE CUT OUT FROM THE INTRODUCER. ALL SEPARATED PORTIONS WERE RETRIEVED. IT WAS NOTED RESISTANCE WAS FELT WITH THE GUIDING CATHETER AND SHEATH DURING REMOVAL. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19241877 ↗
• MalfunctionMar 20, 2024Break; Material Separation; Deformation Due to Compressive Stress; Break; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 5.0X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED ADVANCED IN A PATIENT; HOWEVER, AFTER REMOVAL THE BDC BECAME BENT, FRACTURED AND SEPARATED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER NC TREK WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942191 ↗
• MalfunctionJan 12, 2024Failure to Fold; Off-Label Use; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Failure to Fold; Off-Label Use; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A STENOSED ANASTOMOSIS LESION IN THE LEFT RADIAL ARTERY FISTULA. THE 5.0X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED TO NOMINAL AND THEN DEFLATED BUT THE PHYSICIAN DID NOT WAIT LONG ENOUGH BEFORE REMOVING SO THE BALLOON WAS NOT TOTALLY DEFLATED BEFORE PULLING THROUGH THE SHEATH. THE PHYSICIAN PULLED ON THE BALLOON TO TRY TO GET IN THROUGH THE SHEATH AND SNAPPED THE CATHETER OUTSIDE THE SHEATH DUE TO FORCE THAT WAS APPLIED. THE SHEATH WAS THEN PULLED OUT TO RETRIEVE THE BALLOON. IT WAS NOTED THAT THE BALLOON HAD BUNCHED UP AT THE DISTAL END PREVENTING IT FROM MOVING THROUGH THE SHEATH. THE CASE WAS FINISHED WHEN THE DIFFICULTY IN REMOVAL OCCURRED. NOTHING REMAINS IN THE PATIENT. 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 18508758 ↗
• InjuryNov 28, 2023Deflation Problem; Off-Label Use; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Off-Label Use; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT RENAL ARTERY WITH NO TORTUOSITY AND 60% STENOSIS. THE 5X20 MM NC TREK BALLOON DILATATION CATHETER WAS INFLATED ONCE TO NOMINAL PRESSURE BUT ONLY PARTIALLY DEFLATED. NEGATIVE PRESSURE WAS HELD FOR 20 SECONDS. THE BALLOON HAD TO BE RUPTURED IN ORDER TO BE REMOVED. THE CONTRAST MIX WAS 40% CONTRAST, 60% SERUM. THERE WERE NO ADVERSE PATIENT SEQUELA. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18219427 ↗
• MalfunctionDec 5, 2022Off-Label Use; Difficult to Remove; Material Separation; Off-Label Use; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS LESION IN THE PULMONARY ARTERY. THE 5.0X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND THE LESION TREATED. RESISTANCE WAS NOTED DURING REMOVAL FROM THE ANATOMY AND IT WAS NOTED THAT THE SHAFT SEPARATED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SAME SIZE BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921092 ↗
• MalfunctionSep 28, 2021Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  USER FACILITY MEDWATCH [MEDWATCH #: (B)(4) REPORT RECEIVED STATES: UPON RETRIEVAL OF THE NC TREK CORONARY DILATATION CATHETER 5.0 MM X 20 MM / RAPID EXCHANGE (POST EXPANSION) , THE DEVICE BECAME LODGED IN THE GUIDE CATHETER. AS THE DOCTOR TUGGED A BIT HARDER THE BALLOON SEPARATED INTO TWO PIECES. THE DOCTOR REMOVED THE ENTIRE SYSTEM (BALLOON, GUIDE WIRE AND GUIDE CATHETER) WITH THE BALLOON REMAINDER STUCK IN THE GUIDE CATHETER, BUT SUBSEQUENTLY REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12542808 ↗
• MalfunctionJul 20, 2021Failure to Fold; Difficult to Remove; Failure to Fold; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SAPHENOUS VEIN GRAFT. A 5.0X20MM NC TREK BALLOON DILATATION CATHETER WAS USED FOR POST-DILATATION WITH NO ISSUES AND DEFLATED WITH NO ISSUES; HOWEVER, WHEN REMOVING THE BALLOON IT WOULD NOT INSERT BACK INTO THE UNSPECIFIED GUIDING CATHETER. IT WAS NOTED THE BALLOON FAILED TO REFOLD TIGHTLY. THE BALLOON AND UNSPECIFIED GUIDE CATHETER HAD TO BE REMOVED TOGETHER. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12199859 ↗
• MalfunctionMay 10, 2021Failure to Fold; Difficult to Remove; Material Separation; Failure to Fold; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION WITH NO CALCIFICATION AND NO TORTUOSITY IN THE SAPHENOUS VEIN GRAFT (SVG) TO RIGHT CORONARY ARTERY (RCA). THE NC TREK BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED TWICE TO 8 ATMOSPHERES (ATM) AND 12 ATMS WITHOUT ISSUE. THE BALLOON DEFLATED WITHOUT ISSUE. HOWEVER, DURING REMOVAL OF THE BALLOON CATHETER, THE BALLOON WAS WINGED AND COULD NOT BE WITHDRAWN INTO THE GUIDING CATHETER. AND DURING THE ATTEMPT TO WITHDRAW THE BALLOON CATHETER, THE DISTAL SHAFT SEPARATED AND REMAINED ON THE GUIDE WIRE. THEREFORE, ALL THE DEVICES HAD TO BE REMOVED AS ONE UNIT. 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 11801008 ↗
• MalfunctionFeb 11, 2021Deflation Problem; Difficult to Remove; Material Separation; Deflation Problem; Difficult to Remove; Material Separation

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE SHAFT WAS SEPARATED AT THE GUIDE WIRE EXIT NOTCH AND THE PROXIMAL PORTION WAS NOT RETURNED. FOLLOW-UP WITH THE ACCOUNT CONFIRMED THAT THEY WERE AWARE OF THE SEPARATION AND THE SEPARATED PORTION WAS DISCARDED. ADDITIONALLY, IT WAS REPORTED THAT THE NC TREK BALLOON WAS REPOSITIONED DURING INFLATIONS/DEFLATIONS AND ONLY AFTER THE THIRD INFLATION/DEFLATION DID THE BALLOON FAIL TO DEFLATE. THERE WAS RESISTANCE WITH THE GUIDE CATHETER DURING REMOVAL OF THE NC TREK CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11319151 ↗
• MalfunctionNov 3, 2020Deflation Problem; Off-Label Use; Difficult to Remove; Deflation Problem; Off-Label Use; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNSPECIFIED CAROTID ARTERY. A 5X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED WITH A NON-ABBOTT CEREBRAL PROTECTION DEVICE. AFTER INFLATION, THE BALLOON WAS UNABLE TO BE DEFLATED DESPITE SEVERAL ATTEMPTS, SO THE WHOLE SYSTEM WAS REMOVED TOGETHER. 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 10782452 ↗
• MalfunctionSep 11, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. DURING REMOVAL OF A 5X20MM NC TREK BALLOON, RESISTANCE WAS MET WITH THE GUIDE WIRE. BOTH THE GUIDE WIRE AND BALLOON HAD TO BE REMOVED TOGETHER. 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 10522604 ↗
• DeathJun 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY (RCA). A 5X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATATION, AND THE SHAFT SEPARATED IN THE ANATOMY. THE PATIENT WAS SENT TO SURGERY TO REMOVE THE SEPARATED PORTION. THE SEPARATED PORTION WAS REMOVED, AND THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT TO THE PREVIOUSLY FILED MDR REPORTS, ADDITIONAL INFORMATION WAS RECEIVED: [DURING THE CATHETERIZATION PROCEDURE ON (B)(6) 2020, THE NC TREK BALLOON WAS ATTEMPTED TO BE WITHDRAWN, HOWEVER IT WAS NOT ABLE TO WITHDRAW BECAUSE THE DISTAL PORTION OF THE DEVICE MALFUNCTIONED AND BROKE AT THE DISTAL TIP WHILE BEING AT THE PROXIMAL SEGMENT OF THE RCA EXTENDED INTO THE ASCENDING AORTA. THE DISTAL TIP WAS ATTEMPTED TO REMOVED VIA AN ENDOVASCULAR SNARE, HOWEVER IT WAS UNABLE TO BE CAPTURED TO BE REMOVED. IT WAS ALSO ATTEMPTED TO PASS A CORONARY GUIDEWIRE DISTAL TO THE CATHETER TIP AGAIN WITHOUT SUCCESS. THIS BROKEN PART OF THE CATHETER REMAINED LODGED INSIDE THE PATIENT'S ARTERY. THE PHYSICIAN IMMEDIATELY CONSULTED WITH A CARDIAC AND TH

  Patient problems: Cardiogenic Shock; Foreign Body In Patient; Low Blood Pressure/ Hypotension; Multiple Organ Dysfunction Syndrome; Myocardial Infarction; No Consequences Or Impact To Patient; Respiratory Failure

  MAUDE report 10201242 ↗
• InjuryMar 12, 2020Off-Label Use; Difficult to Remove; Material Rupture; Material Separation; Off-Label Use; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY IN THE SUPERIOR MESENTERIC ARTERY (SMA). THE LESION WAS PRE-DILATED, AND A 4.0 X 38 MM XIENCE SIERRA STENT WAS IMPLANTED SUCCESSFULLY. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND THE STENT WAS WELL APPOSED. A 5.0 X 20 MM NC TREK BALLOON CATHETER WAS ADVANCED FOR POST DILATION. HOWEVER, AT THE THIRD INFLATION AT 16 ATMOSPHERES THE BALLOON RUPTURED. DURING REMOVAL OF THE BALLOON CATHETER, THE DISTAL SHAFT SEPARATED IN TWO PIECES INSIDE THE GUIDING CATHETER AS THERE WAS RESISTANCE BETWEEN THE DEVICES. A SNARE DEVICE WAS USED TO SECURELY WITH WITHDRAWAL THE SEPARATED DISTAL SHAFT. THE PATIENT REMAINED STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9824064 ↗
• InjuryJan 29, 2020Deflation Problem; Off-Label Use; Deflation Problem; Off-Label Use

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE RENAL ARTERY. A 5X20MM NC TREK BALLOON DILATATION CATHETER (BDC) COMPLETELY FAILED TO DEFLATE, SO A NON-ABBOTT NEEDLE DEVICE WAS INTRODUCED TO PUNCTURE AND DEFLATE THE BALLOON. THEN THE BALLOON WAS REMOVED. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9642397 ↗
• InjuryOct 17, 2019Off-Label Use; Difficult to Remove; Material Separation; Off-Label Use; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT RENAL ARTERY. A 5X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE, AND THE SHAFT SEPARATED INSIDE OF AN UNSPECIFIED STENT. A SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE SEPARATED PORTION. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9202825 ↗
• InjuryOct 3, 2019Off-Label Use; Difficult to Remove; Material Separation; Off-Label Use; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A HEAVILY TORTUOUS ILIAC ARTERY WITH HEAVY CALCIFICATION. THE NC TREK DILATATION CATHETER ADVANCED AND DILATATION WAS PERFORMED ONE TIME AT 14 ATMOSPHERES WITHOUT ISSUES. THE BALLOON WAS DEFLATED FOR WITHDRAWAL. UPON RETRACTION INTO THE SHEATH, UNUSUAL RESISTANCE WAS MET AND THE BALLOON HAD SEPARATED FROM THE DELIVERY CATHETER AND EMBOLIZED INTO THE AORTA. A SNARE SUCCESSFULLY REMOVED THE SEPARATED PORTION. NOTHING WAS LEFT IN THE PATIENT'S ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED.

  Patient problems: Embolism

  MAUDE report 9152412 ↗
• MalfunctionAug 6, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. UNSPECIFIED XIENCE STENTS WERE IMPLANTED AT THE LESION AND POST-DILATED WITH A 5.0 X 20 MM NC TREK BALLOON DILATATION CATHETER (BDC). DURING REMOVAL OF THE NC TREK BDC, THE HYPOTUBE (NEAR THE GUIDE WIRE EXIT NOTCH) BECAME SEPARATED IN TWO PIECES, STILL WITHIN THE GUIDING CATHETER. ONCE OUTSIDE OF THE ANATOMY, IT WAS CONFIRMED THAT THE BDC SEPARATED. THE PROCEDURE HAD COMPLETED SUCCESSFULLY AT THAT TIME. THERE WAS NO RESISTANCE NOTED DURING ADVANCEMENT OR WITHDRAWAL OF THE DEVICE. 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 8867076 ↗
• MalfunctionNov 20, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE 5.0 X 20 MM NC TREK BALLOON WAS USED IN A CORONARY ARTERY PROCEDURE PAST DEVICE EXPIRATION DATE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8091526 ↗
• MalfunctionFeb 7, 2018Detachment Of Device Component; Difficult to Remove

  IT WAS REPORTED THAT A 5.0X20MM NC TREK ADVANCED TO THE PROXIMAL RIGHT CORONARY ARTERY LESION AND POST-DILATATION WAS PERFORMED WITHOUT ISSUE ON AN UNSPECIFIED STENT. FOLLOWING BALLOON DEFLATION WITHOUT ISSUE, THE DEVICE WAS REMOVED INTO THE GUIDE CATHETER. ONCE INSIDE THE GUIDE CATHETER, RESISTANCE WAS MET AND THE NC TREK DILATATION CATHETER AND THE GUIDE CATHETER WERE REMOVED AS A SINGLE UNIT. ONCE OUTSIDE THE PATIENTS ANATOMY, THE NC TREK SHAFT WAS PULLED AND SHAFT SEPARATED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7247968 ↗