TREK™ 1012278-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08717648138713), received between Dec 18, 2017 and Apr 29, 2025 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT MILDLY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. ONCE AT THE LESION, THE 4.00X15MM TREK BALLOON RUPTURED AT 11 ATMOSPHERES DURING THE 2ND INFLATION. A NON-ABBOTT DEVICE 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 21928892 ↗
• MalfunctionJul 2, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN A CORONARY ARTERY. THE 4X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE LOADED ONTO A GUIDE WIRE (GW); HOWEVER, THE SHAFT THAT WAS STILL OUTSIDE THE PATIENT'S BODY SEPARATED IN TWO PIECES. THEREFORE, THE PHYSICIAN DISCONTINUED LOADING THE BDC ONTO GW. ANOTHER TREK BDC WAS USED TO CONTINUE 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 19661309 ↗
• MalfunctionSep 8, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT CIRCUMFLEX CORONARY ARTERY. THE TREK BALLOON WAS ADVANCED TO THE LESION AND NEGATIVE WAS PULLED. DURING THE PROCESS OF PULLING NEGATIVE, BLOOD WAS NOTED IN THE INFLATION DEVICE, INDICATING A LEAK. THE TREK BALLOON WAS REMOVED AND ONCE IT GOT OUT OF THE GUIDE CATHETER, THE SHAFT SEPARATED. THE REMAINING PORTION WAS SIMPLY WITHDRAWN. 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 17712051 ↗
• MalfunctionAug 26, 2022Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT PRIOR TO USE ON BOTH BALLOONS THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE SHEATH, THE CATHETERS WERE SOAKED IN SALINE AND BOTH BDCS WERE PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY. THE PROCEDURE WAS TO TREAT A RESTENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 3.50X15MM TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION WITH DIFFICULTY DUE TO THE ANATOMY AND THE BALLOON WAS INFLATED TWO TIMES TO 14 ATMOSPHERES (ATM); HOWEVER, THE BALLOON RUPTURED AT 14 ATM. THE BDC WAS REMOVED FROM THE PATIENT WITH DIFFICULTY DUE TO THE ANATOMY. THEN, A 4.00X15MM TREK BDC WAS ADVANCE WITH DIFFICULTY DUE TO THE ANATOMY AND THE BALLOON WAS INFLATED ALSO TO 14 ATM TWICE; HOWEVER, THE SECOND BALLOON ALSO RUPTURED AT 14 ATM. THE BDC WAS REMOVED FROM THE PATIENT WITH RESISTANCE NOTED DUE TO THE ANATOMY. 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 15306673 ↗
• MalfunctionDec 20, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH 90% STENOSIS, MILD CALCIFICATION, AND HEAVY TORTUOSITY IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE 4.0 X 15 MM RX TREK BALLOON CATHETER WAS ADVANCED WITHOUT RESISTANCE TO THE TARGET LESION. HOWEVER, THE BALLOON RUPTURED AT 12 ATMOSPHERES. A NON-ABBOTT BALLOON CATHETER WAS USED TO PERFORM DILATATION WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 13044245 ↗
• InjuryDec 20, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED RIGHT CORONARY ARTERY (RCA) THAT HAD RESTENOSED 80%. A 4X15MM TREK BALLOON WAS USED DURING THE PROCEDURE AND INFLATED BETWEEN 10-14 ATMOSPHERES. THEN DURING THE FINAL X-RAY CONTROL WITH CONTRAST MEDIUM, THE COMPLETE BALLOON MATERIAL DETACHED AND WAS FLUSHED INTO THE PROXIMAL RCA. ATTEMPTS TO RETRIEVE THE BALLOON MATERIAL WERE UNSUCCESSFUL. THE BALLOON MATERIAL WAS COVERED WITH A 4X15MM XIENCE PRO STENT IN THE PROXIMAL SEGMENT OF THE RCA. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13043983 ↗
• MalfunctionDec 14, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 4X15MM TREK BALLOON FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WAS ALSO MET WITH ANATOMY DURING REMOVAL. ANOTHER BALLOON 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13006070 ↗
• InjuryDec 14, 2021Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE 4.00X15 MM TREK BALLOON DILATATION CATHETER (BDC) DID NOT CROSS THE LESION DUE TO THE ANATOMY. THE PATIENT WAS TREATED WITH ANOTHER TREK BDC. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS RETURNED AND DEVICE ANALYSIS IDENTIFIED A SEPARATED DISTAL SHAFT AND THE SEPARATED PORTION WAS NOT RETURNED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13005731 ↗
• InjurySep 22, 2021Material Separation; Failure to Deflate; Material Separation; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH A KISSING TECHNIQUE. A 2.5X23MM XIENCE STENT WAS IN THE DIAGONAL ARTERY AND A 4X15MM TREK BALLOON WAS IN THE LAD. THERE WAS NO RESISTANCE WHEN ADVANCING BOTH DEVICES IN THE NON-ABBOTT GUIDING CATHETER. THE STENT WAS IMPLANTED WITHOUT ISSUE AND THE STENT DELIVERY SYSTEM WAS REMOVED. THE TREK BALLOON WAS INFLATED ONCE AT NOMINAL PRESSURE WITHOUT ISSUE. HOWEVER, AFTER THE KISSING TECHNIQUE WAS USED, THE TREK BALLOON COMPLETELY FAILED TO DEFLATE. THE BALLOON REMAINED INFLATED AT THE DISTAL PART OF THE GUIDING CATHETER AND WHEN PULLING IT IN THE SHAFT SEPARATED. IN AN ATTEMPT TO RETRIEVE THE BALLOON VIA LASSO, THE BALLOON WAS INTENTIONALLY CRUSHED WITH THE LASSO AND THUS PARTIALLY DEFLATED AND ULTIMATELY RETRIEVED THROUGH THE LEFT RADIAL ARTERY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512542 ↗
• MalfunctionJul 23, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED RENAL ARTERY. AN ATTEMPT TO PRE-DILATE THE LESION WAS MADE WITH A 2.50X15MM TREK BALLOON; HOWEVER, THE BALLOON RUPTURED AT 20 ATMOSPHERES (ATM). A 3.0X12MM UNSPECIFIED BALLOON WAS USED AND THEN THE 4.0X15MM TREK BALLOON WAS ATTEMPTED TO BE USED HOWEVER; RUPTURED AT 4 ATM. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12221396 ↗
• InjuryJul 1, 2021Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 3.5X23MM XIENCE SIERRA STENT WAS IMPLANTED, AND A 4X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATATION. THE BALLOON COULD ONLY PARTIALLY DEFLATE, AND THE BDC COULD NOT BE INSERTED INTO THE INTRODUCER SHEATH. THE ENTIRE SYSTEM WAS REMOVED TOGETHER. THE PATIENT EXPERIENCED THORACIC PAIN, AND MORPHINE WAS USED AS TREATMENT. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: TEARS IN THE TIP AND OUTER MEMBER WERE NOTED ON THE DEVICE WHEN THE BALLOON WAS RETRIEVED INTO THE GUIDING CATHETER. ADDITIONALLY, THE DEVICE WAS ASPIRATED IN THE ANATOMY, AS OPPOSED TO OUTSIDE THE ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 12103617 ↗
• MalfunctionJul 9, 2020Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A LEFT PULMONARY ARTERY INTERVENTION, THE TREK RX WAS TAKEN TO THE LESION, OVER INFLATED AND RUPTURED. THE DEVICE WAS REMOVED WITHOUT ISSUE. NO ADDITIONAL INTERVENTION WAS PERFORMED. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10253590 ↗
• MalfunctionOct 15, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT WHEN OPENING THE WHITE PORTION OF THE PACKING OF THE 4.00X15 MM TREK BALLOON DILATATION CATHETER (BDC), IT WAS NOTED THAT THE PACKAGE WAS ALREADY UNSEALED. SINCE THE PACKAGING WAS ALREADY OPENED, THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THE BDC WAS REPLACED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9194818 ↗
• InjuryDec 18, 2017Detachment Of Device Component; Entrapment of Device; Product Quality Problem; Improper or Incorrect Procedure or Method; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS AND CALCIFIED SAPHENOUS VEIN GRAFT (SVG) TO DIAGONAL LESION. SEVERAL SHEATHS WERE USED AS IT WAS DIFFICULT TO ACCESS THE LESION. RESISTANCE WAS MET DURING ADVANCEMENT OF THE 4.0X15 RX TREK BALLOON DILATATION CATHETER (BDC) TO THE LESION, REQUIRING THE DEVICE TO BE TORQUED SEVERAL TIMES. THE BALLOON WAS INFLATED TWICE, ONCE AT 2 ATMOSPHERES (ATM) FOR 10 SECONDS, AND 6 ATM FOR 20 SECONDS. AS THE BDC WAS PULLED BACK, RESISTANCE WAS MET AND A 3MM PORTION OF THE BALLOON SEPARATED. A XIENCE ALPINE STENT WAS IMPLANTED, EMBEDDING THE SEPARATED PORTION OF THE BALLOON IN THE TARGET LESION. THE PHYSICIAN BELIEVED THAT THE BALLOON BECAME TWISTED DURING THE TORQUEING OF THE DEVICE, RESULTING IN THE TIP BECOMING ENTRAPPED IN THE LESION. THERE WAS CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE DUE TO THE DEVICE ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7127081 ↗