TREK™ 1012271-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08717648138218), received between Jan 16, 2017 and Jul 7, 2025 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (14 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA). A 2.25X12MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES AND ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED. DURING THE INITIAL INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 10 ATMS. THEREFORE THE BDC WAS REMOVED AND A NEW TREK BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22421549 ↗
• MalfunctionMay 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE 2.25X12MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. THE BDC WAS REMOVED AND REPLACED WITH ANOTHER BALLOON TO 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 22003672 ↗
• MalfunctionDec 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL LEFT CIRCUMFLEX CORONARY ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 2.25X12MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH NO RESISTANCE FOR PRE-DILATATION. THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES WHEN A RUPTURE OCCURRED. A 2.25X12MM NC TREK NEO BDC WAS USED TO CONTINUE THE PROCEDURE FOLLOWED BY A 2.5X15MM XIENCE STENT BEING IMPLANTED. 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 21037134 ↗
• MalfunctionOct 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF THE 2.25X12 MM TREK BALLOON DILATATION CATHETER (BDC), THE TECH REMOVED THE DEVICE FROM THE PACKAGING WITHOUT ISSUE AND NO DAMAGE WAS NOTED. WHEN THE DEVICE WAS HANDED TO THE PHYSICIAN, THE DEVICE WAS SEPARATED AT THE SHAFT. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409130 ↗
• MalfunctionDec 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN DISTAL LEFT ANTERIOR DESCENDING (DLAD) ARTERY WITH HEAVY CALCIFICATION. THE 2.25X12MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, A RUPTURE OCCURRED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE ANATOMY. A 2.0X12MM MINI TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 18279658 ↗
• MalfunctionJun 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DIAGONAL ARTERY. THERE WERE 16 BALLOONS USED IN THE PROCEDURE FOR DILATATION. HOWEVER, 8 OUT OF THE 16 BALLOONS USED HAD ISSUES. TWO NC TREK BALLOONS, 3.0X8MM AND 4.0X8MM, LOST PROFILE. FOUR NC TREK BALLOONS, 2.0X20MM, 2.5X15MM, 3.0X15MM AND 3.0X20MM, HAD BALLOON RUPTURES. ANOTHER 2 TREK BALLOONS, 2.25X12MM AND 2.5X15MM, ALSO HAD BALLOON RUPTURES. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT 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 17122038 ↗
• MalfunctionJun 9, 2023Material 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 LESION IN THE DISTAL LEFT CIRCUMFLEX (DLCX) WITH 90% STENOSIS, MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 2.25X12MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS NOT SOAKED IN SALINE BUT WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS RESISTANCE DURING ADVANCEMENT WITH THE ANATOMY AND RUPTURED AT 8 ATMOSPHERES (ATMS) DURING THE FIRST INFLATION. THERE WAS NO RESISTANCE DURING REMOVAL. A NEW TREK RX BALLOON 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 17098566 ↗
• MalfunctionMay 4, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH HEAVY CALCIFICATION, HEAVY TORTUOSITY AND 90% STENOSIS. THE 2.25X12MM TREK RX BALLOON DILATATION CATHETER (BDC) FAILED TO CROSS THE LESION. THEREFORE, AN EXTENSION CATHETER WAS USED, BUT DID NOT CROSS THE LESION. DURING REMOVAL, RESISTANCE WAS MET WITH THE ANATOMY. THE PROCEDURE WAS POSTPONE. 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 16872464 ↗
• MalfunctionSep 14, 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 LEFT ANTERIOR DESCENDING ARTERY. A 2.25X12MM TREK BALLOON WAS THEN ADVANCED IN THE PATIENT WHEN RESISTANCE WITH ANATOMY WAS NOTED, BUT THE BALLOON WAS STILL ABLE TO REACH THE LESION. THE BALLOON WAS INFLATED ONCE BUT RUPTURED AT 7 ATMOSPHERES. THE TREK BALLOON WAS REMOVED AND AGAIN MET RESISTANCE WITH ANATOMY. THEN A ROTABLATOR WAS USED DUE TO THE HEAVY CALCIFICATION WHICH THEN CAUSED A PERFORATION WHICH WAS THEN TREATED VIA A NON-ABBOTT BALLOON. IT WAS CONFIRMED THAT THE TREK BALLOON DID NOT CAUSE OR CONTRIBUTE TO THE PERFORATION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15420300 ↗
• MalfunctionSep 1, 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 MODERATELY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA). A 2.25X12MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE FROM THE ANATOMY BUT REACHED THE TARGET LESION. THE BDC WAS INFLATED ONE TIME TO 8 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITH RESISTANCE FORM THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15342041 ↗
• InjuryFeb 1, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) AND NO ISSUES WERE IDENTIFIED. DURING THE LEFT ANTERIOR DESCENDING ARTERY INTERVENTION, THE BDC WAS ADVANCED TO THE LESION WITHOUT ISSUE. DURING BALLOON INFLATION, AN AIR EMBOLISM WAS NOTED IN THE PATIENT, WHICH WAS NOTED TO BE FROM A CRACK OR TINY HOLE IN THE SHAFT OF THE DEVICE. THE PATIENT STATUS DECLINED QUICKLY. THE PATIENT WAS INTUBATED AND CARDIOPULMONARY RESUSCITATION WAS STARTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Air Embolism; Cardiac Arrest; Respiratory Failure

  MAUDE report 13419750 ↗
• InjuryJan 24, 2022Gas/Air Leak

  PATIENT WAS TAKEN TO THE CARDIAC CATHETERIZATION LAB AND DURING THE PROCEDURE, A CORONARY DILATATION CATHETER WAS USED AND ONCE PLACED AIR WAS INJECTED TO INFLATE THE BALLOON, HOWEVER THERE WAS SOME DEVICE FAILURE CAUSING THE AIR TO LEAK OUTSIDE THE DEVICE CAUSING AN AIR EMBOLISM IN THE PATIENT. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Air Embolism

  MAUDE report 13343200 ↗
• MalfunctionDec 20, 2020Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED DE NOVO DISTAL RIGHT CORONARY ARTERY (DRCA). DURING ADVANCEMENT OF A 2.25X12MM NC TREK BALLOON DILATATION CATHETER RESISTANCE WAS MET WITH ANATOMY AND AT THE FIRST INFLATION THE BALLOON RUPTURED AT AN UNKNOWN PRESSURE. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENTS EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11043116 ↗
• MalfunctionJun 4, 2020Material Rupture; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Material Rupture; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROXIMAL SHAFT OF A 2.25X12MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS NOTED TO BE KINKED. ADDITIONALLY, THE BDC WAS USED AND THE BALLOON RUPTURED. THERE WERE NO REPORTED 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 10120105 ↗
• MalfunctionFeb 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS FIRST OBTUSE MARGINAL LESION THAT WAS 90% STENOSED. THE 2.25X12MM RX TREK BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. THE DEVICE WAS REPLACED WITH AN UNSPECIFIED BALLOON 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 9717411 ↗
• MalfunctionFeb 6, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A 2.25X12 MM TREK BALLOON DILATATION CATHETER (BDC) WAS REQUESTED FOR DURING A CASE. THE BOX INDICATED THE DEVICE WAS A 2.25X12 MM TREK; HOWEVER, THE DEVICE INSIDE THE BOX WAS A 2.75X12 MM TREK BDC. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9677640 ↗
• InjurySep 11, 2019Inflation Problem; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Inflation Problem; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, RE-STENOSED STENT LESION AT A BIFURCATION IN THE POSTERIOR DESCENDING ARTERY (PDA) AND POSTERIOR LEFT VENTRICULAR ARTERY (PLVA). THIS LESION WAS PREVIOUSLY STENTED. THE VESSELS WERE WIRED AND PRE-DILATED WITH SMALLER BALLOONS. THEN, A 2.25 X 12 MM TREK RX WAS ADVANCED TO THE LESION, AND INFLATED BUT DIDN'T DILATE ENOUGH, AS A WAIST WAS NOTED IN THE BALLOON, SO THEY OVER-INFLATED THE BALLOON TO DILATE THE CALCIFIED LESION. THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 28 ATMOSPHERES. RESISTANCE WAS MET DURING REMOVAL AND IT WAS NOTED THAT THE DISTAL TIP OF THE BALLOON SEPARATED AND REMAINED IN THE VESSEL. NO FLOW WAS OBSERVED INTO THE PDA. THE PATIENT BECAME UNSTABLE BUT WAS STABILIZED AND TAKEN URGENTLY TO SURGERY TO REMOVE THE SEPARATED BALLOON SEGMENT. PATIENT WAS STABLE POST-SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism; Low Blood Pressure/ Hypotension

  MAUDE report 8994831 ↗
• MalfunctionAug 22, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 2.25X12MM TREK RX BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED DEVICE. THERE WERE NO REPORTED 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 8922391 ↗
• MalfunctionApr 12, 2018Detachment Of Device Component; Kinked

  IT WAS REPORTED THAT THE 2.25 X 12 MM TREK WAS ADVANCED THROUGH THE GUIDE CATHETER. THE SHAFT KINKED AND SNAPPED, AT A LOCATION OUTSIDE THE PATIENT ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. A SECOND DEVICE WAS USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7426672 ↗
• MalfunctionApr 27, 2017Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO THREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD TORTUOSITY AND HEAVY CALCIFICATION THAT WAS 90% STENOSED. RESISTANCE WAS NOT FELT DURING THE ADVANCEMENT OF THE 2.25MM X 12 MM TREK RX BALLOON DILATATION CATHETER (BDC) FOR PRE-DILATATION AND IT CROSSED THE LESION SUCCESSFULLY; HOWEVER, DURING THE FIRST INFLATION, THE BALLOON WOULD NOT FULLY INFLATE WHEN THE PRESSURE WAS INCREASED TO 10 ATMOSPHERES AND HELD FOR 20 SECONDS. A SECOND INFLATION WAS THEN ATTEMPTED, BUT THE BALLOON RUPTURED AT 12 ATMOSPHERES. A NEW NON-ABBOTT BDC WAS USED FOR PRE-DILATATION AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER A STENT WAS IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6527273 ↗
• MalfunctionJan 16, 2017Deflation Problem

  IT WAS REPORTED PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. THE 2.25X12 MM TREK RX BALLOON WAS INFLATED ONCE JUST OVER 8 ATMOSPHERES, BUT NEGATIVE PRESSURE WAS HELD MANY TIMES AND THE BALLOON DID NOT COMPLETELY DEFLATE. THE TREK RX CATHETER WAS REMOVED WITH THE BALLOON PARTIALLY INFLATED; HOWEVER NO RESISTANCE WAS FELT DURING REMOVAL. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED ALPINE STENT DELIVERY SYSTEM. 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 6254462 ↗