TREK™ 1012278-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648138744), received between Feb 9, 2017 and Jun 13, 2024 — classified as 5 injuries, 6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2024Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION THE RIGHT CORONARY ARTERY (RCA). THE 4.0X30MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS INFLATED WITHOUT ISSUES AND DEFLATED FOR REMOVAL. HOWEVER, THE DISTAL PORTION BROKE OFF WHEN IT HAD RESISTANCE WITH THE GUIDE CATHETER AND SLIGHT FORCE WAS APPLIED BUT SEPARATED PORTION WAS NOTED TO BE IN THE GUIDE WIRE SO THE GUIDE WIRE WAS SIMPLY REMOVED. THE PROCEDURE WAS COMPLETED AT THIS TIME. 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 19533883 ↗
• MalfunctionJun 22, 2023Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE PULMONARY ARTERY. A 4.00X30MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND INFLATED ONE TIME TO 6 ATMOSPHERES (ATM) WHEN A BALLOON RUPTURE OCCURRED. THE BDC WAS REMOVED, AND A SECOND, SAME SIZE TREK BDC WAS ADVANCED. THE SECOND BALLOON WAS INFLATED ONE TIME TO 6 ATMOSPHERES (ATM) WHEN THIS BALLOON RUPTURED AS WELL. A THIRD, SAME SIZE TREK BDC WAS USED WITHOUT ISSUE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17182877 ↗
• MalfunctionJun 22, 2023Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE PULMONARY ARTERY. A 4.00X30MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND INFLATED ONE TIME TO 6 ATMOSPHERES (ATM) WHEN A BALLOON RUPTURE OCCURRED. THE BDC WAS REMOVED, AND A SECOND, SAME SIZE TREK BDC WAS ADVANCED. THE SECOND BALLOON WAS INFLATED ONE TIME TO 6 ATMOSPHERES (ATM) WHEN THIS BALLOON RUPTURED AS WELL. A THIRD, SAME SIZE TREK BDC WAS USED WITHOUT ISSUE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17182876 ↗
• InjuryJun 24, 2022Off-Label Use; Difficult to Remove; Material Separation; Off-Label Use; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THIS WAS A PROCEDURE, PERFORMED TO TREAT A TARGET LESION IN THE LOWER EXTREMITY. THE UNSPECIFIED TREK DILATATION CATHETER WAS USED; HOWEVER, DURING REMOVAL, THE BALLOON SEPARATED. THREE SNARE DEVICES WERE USED TO REMOVE THE SEPARATED SEGMENT AND PULL IT INTO THE SHEATH. THE SHEATH AND SEPARATED BALLOON SEGMENT WERE REMOVED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS CONTINUED AND COMPLETED WITHOUT ANY ADDITIONAL ISSUES. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14811405 ↗
• InjuryDec 20, 2021Off-Label Use; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Off-Label Use; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT TIBIAL ARTERY. TWO 4X30MM TREK BALLOONS WERE USED IN THE SAME PROCEDURE. BOTH WERE INFLATED TWICE AT 12 ATMOSPHERES WITHOUT ISSUES. HOWEVER, THE FIRST TREK BALLOON DURING REMOVAL RESISTANCE WAS MET WHEN THE BALLOON SEPARATED AND WAS THEN SUCCESSFULLY SNARED OUT. FOR THE SECOND TREK BALLOON, DURING REMOVAL RESISTANCE WAS MET WHEN THE BALLOON SEPARATED AND WAS LEFT IN THE BODY AND CRUSHED AGAINST THE ARTERY WITH A STENT. RESISTANCE DURING REMOVAL FOR BOTH BALLOONS WAS MET WITH AN UNSPECIFIED SOURCE. ANOTHER NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13044520 ↗
• InjuryDec 20, 2021Off-Label Use; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Off-Label Use; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT TIBIAL ARTERY. TWO 4X30MM TREK BALLOONS WERE USED IN THE SAME PROCEDURE. BOTH WERE INFLATED TWICE AT 12 ATMOSPHERES WITHOUT ISSUES. HOWEVER, THE FIRST TREK BALLOON DURING REMOVAL RESISTANCE WAS MET WHEN THE BALLOON SEPARATED AND WAS THE SUCCESSFULLY SNARED OUT. FOR THE SECOND TREK BALLOON, DURING REMOVAL RESISTANCE WAS MET WHEN THE BALLOON SEPARATED AND WAS LEFT IN THE BODY AND CRUSHED AGAINST THE ARTERY WITH A STENT. RESISTANCE DURING REMOVAL FOR BOTH BALLOONS WAS MET WITH AN UNSPECIFIED SOURCE. ANOTHER NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13044454 ↗
• MalfunctionApr 14, 2020Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  RETURNED DEVICE ANALYSIS IDENTIFIED THE SHAFT WAS SEPARATED. THE ACCOUNT CONFIRMED THAT THIS OCCURRED AFTER USE AND WAS DUE TO REMOVING THE CATHETER FROM THE INTRODUCER SHEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9958999 ↗
• MalfunctionFeb 26, 2020Off-Label Use; Material Rupture; Difficult to Advance; Off-Label Use; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT COMMON CAROTID ARTERY. A 5X30MM RX VIATRAC PLUS BALLOON DILATATION CATHETER (BDC) MET RESISTANCE WITH THE HEAVY CALCIFICATION DURING ADVANCEMENT AND RUPTURED AT 5 ATMOSPHERES DURING THE FIRST INFLATION. A 4.0X30MM TREK RX BDC ALSO MET RESISTANCE DURING ADVANCEMENT AND RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. AN 8X25MM NON-ABBOTT STENT WAS THEN IMPLANTED AND POST-DILATED 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 9759451 ↗
• InjuryAug 7, 2019Deflation Problem; Off-Label Use; Difficult to Remove; Material Separation; Deflation Problem; Off-Label Use; Difficult to Remove; Material Separation

  SUBSEQUENT TO THE INITIALLY FILED MEDWATCH REPORT, RETURN ANALYSIS NOTED AN UNKNOWN WHISPER GUIDE WIRE RETURNED FROZEN IN THE GUIDE WIRE LUMEN OF THE RX TREK CATHETER. THE POLYMER COATING WAS NOTED TO BE DAMAGED. PER THE ACCOUNT, THE POLYMER DAMAGE LIKELY OCCURRED DURING THE ATTEMPT TO REMOVE THE SEPARATED PORTION OF THE RX TREK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8870490 ↗
• InjuryFeb 2, 2018Detachment Of Device Component; Inflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MODERATE TO HEAVILY CALCIFIED, 80% STENOSED TIBIOPERONEAL (TP TRUNK) ARTERY. A 4.00 X 30 MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS SELECTED FOR THE PROCEDURE. THE BDC WAS ADVANCED WITH NO RESISTANCE FELT TO THE LESION AND THE BALLOON WOULD NOT INFLATE. DURING REMOVAL OF THE BDC FROM THE ANATOMY ONLY A PORTION OF THE SHAFT CAME OUT OF THE PATIENT. IT WAS OBSERVED THAT THE DISTAL PORTION OF THE SHAFT WITH THE BALLOON HAD SEPARATED FROM THE HYPOTUBE PORTION OF THE SHAFT. SEVERAL UNSUCCESSFUL ATTEMPTS WITH VARIOUS METHODS INCLUDING BALLOON ENTRAPMENT, SINGLE LOOP SNARE AND A TRI-LOOP SNARE OF VARIOUS SIZES WERE MADE TO RETRIEVE THE SEPARATED DISTAL PORTION OF THE BDC FROM THE ANATOMY. THE PATIENT WAS SENT TO SURGERY TO HAVE THE SEPARATED DISTAL PORTION WITH THE BALLOON REMOVED FROM THE ANATOMY. THE PATIENT WAS TAKEN TO THE ICU POST-PROCEDURE. ON (B)(6) 2018 THE PATIENT WAS TAKEN BACK TO THE CATH LAB WHERE A SUCCESSFUL INTERVENTION WAS PERFORMED ON THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7235360 ↗
• MalfunctionFeb 9, 2017Difficult to Remove

  IT WAS REPORTED THIS WAS AN EMERGENT PROCEDURE TO TREAT A 100% CLOTTED SAPHENOUS GRAFT TO THE OBTUSE MARGINAL. A THROMBECTOMY WITH ANGIOJET WAS PERFORMED. THEN, THE TREK RX 4.0 X 30 MM BALLOON DILATATION CATHETER WAS ADVANCED OVER THE XT FIELDER GUIDE WIRE AND INFLATED 3 TIMES TO 14 ATMOSPHERES BUT WHEN THE TREK RX WAS BEING REMOVED, IT FROZE ON THE WIRE. THE BALLOON WAS FULLY DEFLATED PRIOR TO REMOVAL. BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. THERE WAS NO REPORTED RESISTANCE DURING REMOVAL OF THE STYLET OR PROTECTIVE SHEATH. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6315865 ↗