TREK™ 1012276-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08717648138560), received between Apr 10, 2017 and Feb 25, 2026 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MILDLY TORTUOUS MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 3.50X12MM TREK RX BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS MET DUE TO ANATOMY. ONCE AT THE LESION FOR PRE-DILATION, THE TREK BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE INITIAL INFLATION. THE TREK RX BDC WAS WITHDRAWN, AND A NEW TREK BDC WAS USED TO COMPLETE THE PROCEDURE.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 24448782 ↗
• MalfunctionJan 6, 2026Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LAD. DURING ADVANCEMENT OF THE 3.50X12MM TREK BALLOON DILATATION CATHETER (BDC) THROUGH AN UNSPECIFIED GUIDELINER, RESISTANCE WAS MET DUE TO THE GUIDELINER AND DID NOT CROSS. UPON REMOVAL, RESISTANCE WAS MET DUE TO THE GUIDELINER AND MORE FORCE WAS NEEDED TO REMOVE THE BDC. THE SHAFT OF THE BDC WAS NOTED TO SEPARATE AND SIMPLY WITHDRAWN BY REMOVING THE GUIDELINER AND TREK BDC AS ONE UNIT. A NEW TREK BDC AND GUIDELINER WERE USED 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 23979407 ↗
• MalfunctionOct 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 75% STENOSED. ONCE AT THE LESION FOR PRE-DILATATION, THE BALLOON OF A 3.50X12MM TREK RX BALLOON DILATATION CATHETER RUPTURED AT 6 ATMOSPHERES DURING THE FIRST INFLATION. A NON-ABBOTT BALLOON WAS USED TO CONTINUE ON WITH 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 23361478 ↗
• InjuryJan 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 95% STENOSED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 2.5X15MM TREK BALLOON DILATATION (BDC) WAS KINKED PRIOR TO BE BEING ADVANCED THROUGH A CO-PILOT DEVICE AND THE SHAFT OF THE BDC BROKE IN HALF DUE TO ERROR USE BY THE SCRUB TECH. THE BDC WAS NOT USED IN THE PROCEDURE. THEN, THE 3.5X12MM TREK BALLOON DILATATION CATHETER SHAFT BROKE IN TWO PIECES DURING ADVANCEMENT WHILE INSIDE A 6 FR GUIDE LINER. THEREFORE, A AN UNSPECIFIED BALLOON WAS ADVANCED TO THE DISTAL PART OF THE GUIDE LINER AND THEN INFLATED TO REMOVE ALL DEVICES AS A SINGLE UNIT. BALLOONING AND STENTING WERE PERFORMED TO FINISH THE PROCEDURE. THERE WAS NO PATIENT ADVERSE EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21117779 ↗
• MalfunctionNov 8, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 3.5X12MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS USED, HOWEVER, THE BALLOON FAILED TO DEFLATE. THE DEVICE WAS ULTIMATELY WITHDRAWN DEFLATED. 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 18092575 ↗
• MalfunctionJul 28, 2023Break; Inflation Problem; Leak/Splash; Break; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. THE 3.5X12MM TREK RX BALLOON DILATATION CATHETER (BDC) FAILED TO INFLATE AND A HAIRLINE CRACK WAS FOUND AT THE INFLATION HUB DUE TO A DISCERNIBLE LEAK. ANOTHER TREK 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 17419360 ↗
• MalfunctionJun 5, 2023Off-Label Use; Difficult to Remove; Material Separation; Stretched; Off-Label Use; Difficult to Remove; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PULMONARY ARTERY. THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED, FOLLOWED BY 3.5X12MM TREK BALLOON DILATATION CATHETER (BDC). THE BDC WAS INFLATED 2-3 TO NOMINAL PRESSURE AND DEFLATED WITHOUT ISSUE. DURING REMOVAL OF THE BDC, IT BECAME STUCK WITH THE BMW. STRETCHING AT THE SHAFT WAS NOTED AND SEPARATION OF THE DEVICE OCCURRED AT THE SHAFT. THE SEPARATED PORTION REMAINED ON THE GUIDE; THEREFORE, THE GUIDE WIRE AND BDC WERE REMOVED ALL TOGETHER WITH NOTHING LEFT IN THE PATIENT. A NEW TREK AND BMW WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS 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 17061447 ↗
• InjuryMay 11, 2023Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Deflate; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Deflate

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, AN UNSPECIFIED BALANCE MIDDLEWEIGHT GUIDE WIRE WAS RETURNED FROZEN WITH THE BALLOON DILATATION CATHETER. ADDITIONAL INFORMATION REPORTED THAT AFTER THE BDC SEPARATED, IT WAS NOTED TO BE STUCK ON THE GUIDE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16915110 ↗
• MalfunctionJan 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, 99% STENOSED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA). A 3.5X12MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND INFLATED ONE TIME TO 14 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16108371 ↗
• MalfunctionOct 12, 2022Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 3.5X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS NOT SOAKED IN SALINE PRIOR TO USE AND WAS PREPPED INSIDE THE ANATOMY. DURING THE 3RD INFLATION TO 10 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. AN UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO AVERSE 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 15588260 ↗
• InjuryFeb 2, 2021Failure to Fold; Material Rupture; Material Separation; Stretched; Failure to Fold; Material Rupture; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED AND CALCIFIED LESION LOCATED IN THE PROXIMAL RAMUS AND LEFT ANTERIOR DESCENDING CORONARY ARTERIES. THE TREK RX BALLOON WAS ADVANCED TO THE LESION. DURING THE FIRST INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED AND THE SHAFT SEPARATED. THE PATIENT EXPERIENCED CHEST PAIN AND ST ELEVATION, WHICH WAS TREATED WITH MEDICATION. THE COMPLETE DEVICE WAS EASILY REMOVED IN ONE PIECE. THE BALLOON APPEARED ELONGATED AND THINNER THAN NORMAL. A XIENCE SIERRA STENT WAS IMPLANTED AND THE PATIENT RECOVERED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Non specific EKG/ECG Changes

  MAUDE report 11267785 ↗
• MalfunctionSep 11, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A 90% STENOSED, MILDLY TORTUOSITY, AND MODERATELY CALCIFIED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.50X12MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPPED OUTSIDE THE ANATOMY PRIOR TO USE WITHOUT ANY ISSUES. THE BDC WAS ADVANCED WITHOUT RESISTANCE AND THE BALLOON WAS INFLATED TWICE; HOWEVER, IT RUPTURED BELOW RATE OF BURST PRESSURE AT 10 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10525395 ↗
• InjuryNov 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SEVERE MULTIVESSEL CORONARY ARTERY DISEASE AND THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, STENOSED LESION AT THE BIFURCATION OF THE LEFT MAIN ARTERY INTO THE RAMUS INTERMEDIUS AND CIRCUMFLEX ARTERY. A 3.0X38 MM XIENCE SIERRA STENT WAS DEPLOYED SUCCESSFULLY AT 18 ATMOSPHERES AT THE LEFT MAIN TO RAMUS INTERMEDIUS ARTERY. POST DILATATION WAS THEN PERFORMED AT THE BIFURCATION USING THE KISSING BALLOON (DILATATION) TECHNIQUE WITH A NON-COMPLIANT UNSPECIFIED BALLOON DILATATION CATHETER (BDC) AND A 3.5 X12 MM TREK BDC AT 8 ATMOSPHERES. DURING INFLATION, THE BALLOON OF THE TREK BDC RUPTURED CAUSING A DISSECTION. THE PATIENT DEVELOPED HYPOTENSION, BRADYCARDIA, AND ULTIMATELY PULSELESS ELECTRICAL ACTIVITY. MEDICATION WAS ADMINISTERED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. ANGIOGRAM SHOWED TIMI GRADE 0 FLOW. AIR EMBOLI WAS SUSPECTED AND AN AIR BUBBLE WAS ASPIRATED. TIMI FLOW WAS RESTORED BACK TO GRADE 3 AND THE PATIENT STABILIZED QUICKLY. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Air Embolism; Bradycardia; Cardiac Arrest; Intimal Dissection; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 9370805 ↗
• MalfunctionOct 2, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED, HEAVILY TORTUOUS, HEAVILY CALCIFIED, DE NOVO LESION LOCATED IN THE LEFT POSTERIOR LATERAL CORONARY ARTERY. A 3.5X12 MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITHOUT ISSUE; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES. THE BDC WAS REMOVED WITHOUT ISSUE, AND A NEW NON-ABBOTT BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7928402 ↗
• MalfunctionOct 9, 2017Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION IN THE DISTAL LEFT MAIN (LM) CORONARY ARTERY. AN UNSPECIFIED STENT WAS PLACED IN THE LM INTO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. KISSING BALLOON ANGIOPLASTY WAS PERFORMED WITH TWO TREK BALLOON DILATION CATHETERS (BDC) FOR THE BIFURCATED LESION. A 3.5 X 12 MM TREK BDC WAS FIRST PLACED IN THE LM TO LAD AND INFLATED AT 12 ATMOSPHERES FOR 10 SECONDS. THE SECOND 3.0 X 15 MM TREK BDC WAS PLACED IN THE LM TO CIRCUMFLEX (CX) AND INFLATED AT 16 ATMOSPHERES FOR 7 SECONDS. DURING DEFLATION, IT WAS NOTED THAT THE 3.5 X 12 MM TREK DEFLATED PARTIALLY. THE ENTIRE SYSTEM WAS REMOVED, INCLUDING THE GUIDING CATHETER AND BOTH A SION BLUE ASAHI GUIDE WIRE AND A NON-ABBOTT GUIDE WIRE. THE TREK WAS WITHDRAWN PARTIALLY INFLATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY POST-DILATING THE LM WITH A NON-ABBOTT BALLOON. THERE WAS NO HARM DONE TO THE PATIENT. 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 6930263 ↗
• MalfunctionApr 10, 2017Difficult to Remove

  REPORTEDLY, RESISTANCE REMOVING THE PROTECTIVE SHEATH OFF A 3.5X12MM TREK RX BALLOON DILATATION CATHETER WAS FELT. 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 6478533 ↗