TREK™ 1012272-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 08717648138287), received between Aug 2, 2016 and Sep 30, 2026 — classified as 10 injuries, 90 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (50 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 100 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Rupture; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948936 ↗
• MalfunctionMay 22, 2026Material Separation

  IT WAS REPORTED THAT THE PACKAGING OF THE 2.50X12MM TREK BALLOON DILATATION CATHETER WAS OPENED, THE PROXIMAL SHAFT WAS OBSERVED TO BE SEPARATED. A NEW 2.50X12MM TREK BDC WAS USED TO PERFORM PRE-DILATION. A NON-ABBOTT STENT WAS IMPLANTED AND A 2.50X20MM NC TREK NEO WAS USED TO PERFORM POST-DILATATION. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT WITH THE COMPLAINT DEVICE, AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257692 ↗
• MalfunctionMay 14, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 2.50X12MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. DURING THE FIRST INFLATION AT 8 ATMOSPHERES, A BALLOON RUPTURE OCCURRED. THE BDC WAS REMOVED AND ANOTHER BALLOON 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 25173120 ↗
• MalfunctionMay 12, 2026Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT PRIOR TO USE THE PROXIMAL SHAFT OF THE 2.5X12MM TREK BALLOON DILATATION CATHETER (BDC) WAS NOTED TO BE KINKED AND THE HUB SEPARATED FROM THE BDC DURING PREPARATION. THE BDC WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25156849 ↗
• MalfunctionMar 17, 2026Deflation Problem; Inflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO CIRCUMFLEX ARTERY LESION. DURING PREPARATION OF THE 2.50X12 MM TREK RX BALLOON DILATATION CATHETER (BDC), DIFFICULTY WAS NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE BDC WAS PREPPED AND ADVANCED FOR PRE-DILATION. THE BALLOON WAS INFLATED ONCE AT 8 ATM; HOWEVER, THE BALLOON DID NOT PROPERLY INFLATE. NEGATIVE PRESSURE WAS APPLIED FOR 3 TO 5 SECONDS; HOWEVER, THE BALLOON WAS SLOW TO DEFLATE. EVENTUALLY, THE BALLOON WAS SUCCESSFULLY DEFLATED AND REMOVED. AN ADDITIONAL TREK BDC WAS USED TO COMPLETE THE PROCEDURE. 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 24621326 ↗
• MalfunctionFeb 16, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, HEAVY CALCIFICATION , MILD TORTUOSITY, MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD) LESION. A 2.50X12 MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED BEFORE PATIENT USE AS PER THE INSTRUCTIONS FOR USE WITHOUT ISSUE. THE BDC WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION WITHOUT ISSUE. HOWEVER, DURING THE FIRST INFLATION BETWEEN 13 AND 14 ATM, THE BALLOON RUPTURED. A NEW 2.5X12 MM SAPPHIRE NC24 BDC WAS USED TO COMPLETE THE PROCEDURE. 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 24348744 ↗
• MalfunctionFeb 16, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. WHEN ATTEMPTING TO INFLATE THE 2.50X12MM TREK RX BALLOON DILATATION CATHETER, THE BALLOON FAILED TO INFLATE AND WAS LOSING PRESSURE. A 2.5X15MM SAPPHIRE 3 BALLOON 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 24345724 ↗
• MalfunctionFeb 11, 2026Material Separation

  IT WAS REPORTED THAT THE 2.50 X 12 MM TREK RX BALLOON DILATATION CATHETER WAS SUCCESSFULLY USED AND UPON REMOVAL, THE PROXIMAL END OF THE SHAFT NEXT TO THE CONNECTOR SEPARATED INTO TWO PIECES. 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 24314801 ↗
• InjuryFeb 3, 2026Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 2.5X12MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED INTO THE PATIENT AND THE BALLOON RUPTURED. THE BALLOON THEN CAME OFF THE SHAFT. THE PATIENT WAS SENT TO EMERGENCY SURGERY AND REMAINED HOSPITALIZED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24252885 ↗
• MalfunctionFeb 2, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATATION, THE 2.5X12MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED TO 6 ATMOSPHERES (ATM); HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. 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 24240904 ↗
• MalfunctionJan 7, 2026Material Separation

  IT WAS REPORTED THAT THE 2.5X12 MM TREK CATHETER BROKE IN TWO PIECES, APPROXIMATELY 30CM PROXIMAL TO THE GUIDEWIRE EXIT NOTCH DURING A CASE TO TREAT THE OSTIAL RAMUS CORONARY ARTERY. THE ACCESS SITE WAS VIA THE RIGHT RADIAL ARTERY WITH A 6F CORDIS SHEATH. THOUGH REQUESTED, IT IS UNKNOWN HOW THE SEPARATED SEGMENT WAS REMOVED FROM THE PATIENT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THE PATIENT IS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990499 ↗
• MalfunctionDec 1, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION, HEAVY TORTUOSITY AND 100% STENOSIS. A NON-ABBOTT BALLOON WAS ADVANCED AND INFLATED FIRST BUT RUPTURED. THE 2.5X12 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE WITH THE ANATOMY NOTED. THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES AND A PINHOLE RUPTURE WAS NOTED. ULTIMATELY, THE LESION WAS DEBULKED AND A STENT WAS IMPLANTED AND POST DILATED. 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 23685750 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT THE 2.5X12MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS NOTED TO BE BROKEN OUT OF THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT 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 23279153 ↗
• MalfunctionOct 2, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS PROVIDED THAT REPORTED RESISTANCE WAS FELT BETWEEN THE BALLOON AND THE LESION WHEN ADVANCING THE DEVICE TO THE TARGET SITE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23203966 ↗
• MalfunctionMay 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA). A 2.5X12MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND ADVANCED TO THE LESION WITH NO NOTED ISSUES; HOWEVER, DURING THE SECOND INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 8ATMS. THEREFORE, ANOTHER DEVICE WAS USED AND THE PROCEDURE WAS CONTINUED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066583 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED DURING THE PROCEDURAL PREPARATION THAT A FRACTURE WAS NOTED ON A 2.5X12MM TREK RX BALLOON DILATATION CATHETER (BDC) WHEN THE DEVICE WAS OPENED FROM ITS PACKAGE. AN UNKNOWN BDC WAS THEN USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT NOR CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881896 ↗
• MalfunctionApr 3, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MILDLY TORTUOUS DISTAL LEFT CIRCUMFLEX CORONARY ARTERY THAT IS 90% STENOSED. AN INTRAVASCULAR ULTRASOUND CATHETER FAILED TO CROSS THE LESION. DURING ADVANCEMENT OF A 2.50X12MM TREK BALLOON DILATATION CATHETER, RESISTANCE WAS MET WITH ANATOMY BUT ULTIMATELY CROSSED THE LESION. ONCE AT THE LESION, THE TREK BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. DILATION WAS PERFORMED WITH 2.25X10MM AND 2.5X20MM NON-ABBOTT BALLOONS 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 21767268 ↗
• MalfunctionMar 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE MID LEFT CIRCUMFLEX ARTERY. AFTER A 2.5X12MM TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES, IT WAS ADVANCED INTO THE ANATOMY AND ATTEMPTED TO BE USED FOR VESSEL PRE-DILATATION; HOWEVER, DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 8 ATM. THE BDC WAS REPLACED WITH A NEW TREK BDC AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21577805 ↗
• MalfunctionJan 9, 2025Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  SUBSEQUENT TO THE INITIAL REPORT BEING FILED, THE INITIALLY REPORTED 2.5X15MM TREK BALLOON DILATATION CATHETER WAS ACTUALLY A 2.5X12 MM TREK BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21117052 ↗
• InjuryNov 22, 2024Inflation Problem; Material Rupture; Improper or Incorrect Procedure or Method; Inflation Problem; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. THE 2.5X12 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION; HOWEVER THE BALLOON WAS PIERCED [RUPTURED] AND COULD NOT BE INFLATED. THIS LED TO AIR BUBBLES SHOWING ON ECHOGRAPHY. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Air Embolism

  MAUDE report 20759528 ↗
• MalfunctionOct 8, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 2.5X12MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR PRE-DILATATION AND WITH RESISTANCE WAS NOTED DUE TO THE ANATOMY. THE BALLOON WAS INFLATED TO 14 ATMOSPHERES (ATM); HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION. THE BDC WAS REMOVED FROM THE PATIENT AND ANOTHER TREK BALLOON 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 20398048 ↗
• MalfunctionSep 30, 2024Material Rupture; Deformation Due to Compressive Stress; Difficult to Advance; Material Rupture; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT CIRCUMFLEX CORONARY ARTERY WITH MILD CALCIFICATION. THE 2.5X12MM TREK BALLOON DILATATION CATHETER (BDC) WAS PREPPED PER INSTRUCTIONS FOR USE. THE BDC WAS ADVANCED AND RESISTANCE WAS NOTED WITH A NON-ABBOTT HEMOSTASIS VALVE. THE BALLOON WAS ATTEMPTED TO BE INFLATED TO 12 ATMOSPHERES TWICE; HOWEVER, THE BALLOON DID NOT HOLD PRESSURE. THE DEVICE WAS REMOVED AND THE CATHETER WAS NOTED TO BE KINKED AND THE BALLOON HAD A PUNCTURE. ANOTHER ABBOTT BDC WAS USED TO CONTINUE 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 20334452 ↗
• MalfunctionSep 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN REMOVING THE 2.50X12MM RX TREK BALLOON DILATATION CATHETER (BDC) FROM THE DISPENSER HOOP, THE HUB SEPARATED FROM THE PROXIMAL SHAFT. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20308913 ↗
• MalfunctionSep 19, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE 2.5X12MM TREK BALLOON DILATATION CATHETER DID NOT DEFLATE PROPERLY. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20257970 ↗
• MalfunctionAug 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 2.5X12MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION UNDER 8 ATMOSPHERES (ATMS). ANOTHER 2.5X12MM 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 20076522 ↗