MINI TREK™ 1012270-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08717648138188), received between Oct 31, 2019 and Mar 26, 2026 — classified as 3 injuries, 13 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 16, 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.

• MalfunctionMar 26, 2026Difficult to Remove; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. AFTER ROTATIONAL ATHERECTOMY (ROTA) WAS PERFORMED, THE PATIENT WAS NOTED TO BE ACTIVELY BLEEDING. THE 2 X 30 MM MINI TREK BALLOON DILATION CATHETER (BDC) WAS ADVANCED TO ACHIEVE HEMOSTASIS. AFTERWARDS, THE BDC WAS REMOVED FROM THE PATIENT. THEN, A GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE ADVANCED; HOWEVER, RESISTANCE WAS NOTED WITH THE GUIDE CATHETER. AN UNSPECIFIED GUIDEWIRE EXCHANGE WAS PERFORMED AND THE GRAFTMASTER STENT WAS ABLE TO BE SUCCESSFULLY IMPLANTED. POST STENT DEPLOYMENT A BALLOON MARKER FROM THE MINI TREK BDC WAS NOTED TO HAVE SEPARATED IN THE GUIDE CATHETER. 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 24695405 ↗
• MalfunctionMar 11, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 2.0X30MM RX MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED. DURING THE FIRST INFLATION AT 6 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 24567550 ↗
• MalfunctionFeb 9, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 2X30 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED. THE BALLOON WAS INFLATED ONCE TO 14 ATMOSPHERES AND RUPTURED. A NEW SAME SIZE MINI 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 24291980 ↗
• MalfunctionOct 22, 2025Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE TIP OF A 2.00X30MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) WAS NOTED TO BE TWISTED IN THE PACKAGING. A NEW MINI TREK RX BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT, AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENTLY, RETURNED DEVICE ANALYSIS OBSERVED THE BDC INNER AND OUTER MEMBRANE SEPARATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23361321 ↗
• MalfunctionApr 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN REMOVING THE 2.0X30MM MINI TREK BALLOON DILATATION CATHETER FROM THE HOOP DISPENSER COIL THE BALLOON WAS STUCK TOGETHER WITH THE STYLET AND WAS NOTED THE DEVICE WAS DISTAL SHAFT WAS SEPARATED INTO TWO SEPARATE PIECES. A 2.0X20MM MINI TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 21911278 ↗
• MalfunctionFeb 19, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA). AFTER A 2.00X30MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED, WITH NO NOTED ISSUES, THE BDC WAS ATTEMPTED TO BE USED FOR VESSEL DILATATION. HOWEVER, DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 6ATM. THEREFORE, THE BDC WAS REMOVED AND REPLACED WITH ANOTHER TREK BDC, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413745 ↗
• MalfunctionFeb 20, 2024Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. A 2.0X30MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED INTO A 7FR GUIDE CATHETER, HOWEVER, THE BALLOON MET RESISTANCE WITH THE GUIDING CATHETER AND BECAME STUCK. WHEN THE PHYSICIAN REMOVED THE BALLOON WITH FORCE, THE BALLOON BECAME SEPARATED FROM THE HYPOTUBE. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18742851 ↗
• MalfunctionOct 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION AND 90% STENOSIS. THE 2.0X30 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND WAS INFLATED BUT A RUPTURE OCCURRED DURING THE FIRST INFLATION TO 8 ATMOSPHERES FOR 5 SECONDS. A NON-ABBOTT BALLOON 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 17943556 ↗
• InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DISTAL CIRCUMFLEX ARTERY. THE 2.0X30MM MINI TREK BALLOON DILATATION CATHETER WAS INFLATED AND ONCE DEFLATED A PERFORATION WAS NOTED. THE BALLOON WAS INFLATED IN AN ATTEMPT TO SEAL THE PERFORATION; HOWEVER, WAS UNSUCCESSFULLY. SMALL COILS WERE USED TO STOP THE VESSEL FROM BLEEDING. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 17931309 ↗
• MalfunctionJul 27, 2022Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION, MILD TORTUOSITY, AND 90% STENOSIS. THE 2.0X30 MM MINI TREK BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE FIRST INFLATION TO 17 ATMOSPHERES (ATM). THERE WAS RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND REMOVAL. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15117228 ↗
• MalfunctionJul 26, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION. THE 2.0X30 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE WITH THE ANATOMY AND RUPTURED ON THE FIRST INFLATION AT 12 ATMOSPHERES (ATM). THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A SMALLER, SHORTER BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15105951 ↗
• MalfunctionJul 21, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY, AND 90% STENOSIS. THE TREK BALLOON DILATATION CATHETER (BDC) COULD NOT CROSS THE LESION AND THERE WAS DIFFICULTY WITH THE LESION DURING REMOVAL. 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 15075654 ↗
• MalfunctionApr 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD) WITH HEAVY CALCIFICATION. THE 2.00X30MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION AFTER 10 SECONDS. THE BDC WAS REMOVED FROM THE PATIENT, WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT IN THE PROCEDURE. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14254844 ↗
• InjuryNov 19, 2020Inflation Problem; Leak/Splash; Improper or Incorrect Procedure or Method; Inflation Problem; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY. A 2X30MM MINI TREK BALLOON WAS PREPARED AS USUAL BUT NOT SOAKED PRIOR TO USE. THE DEVICE WAS ADVANCED TO THE LESION AND WHEN INFLATED, THERE WAS NO MOVEMENT ON THE MANOMETER BUT THE BALLOON INFLATED ONLY A LITTLE BIT, BUT WAS NOTED AS LOSING PRESSURE. THE PATIENT DEVELOPED CHEST PAIN AND ST-ELEVATION FOR APPROXIMATELY 5 MINUTES. THE BALLOON WAS SIMPLY REMOVED AND A STENT WAS IMPLANTED TO SUCCESSFULLY TREAT THE CHEST PAIN AND ST ELEVATION. AFTERWARDS WHEN FLUSHING THE BALLOON OUTSIDE THE ANATOMY, A LEAKAGE WAS NOTED AT THE MID SHAFT. THE PATIENT IS DOING FINE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Non specific EKG/ECG Changes

  MAUDE report 10870042 ↗
• MalfunctionOct 20, 2020Inflation Problem; Leak/Splash; Material Rupture; Material Split, Cut or Torn; Inflation Problem; Leak/Splash; Material Rupture; Material Split, Cut or Torn

  IT WAS REPORTED THAT A 2.0X30MM MINI TREK RX BALLOON DILATATION CATHETER FAILED TO INFLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED BALLOON CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED GOODS ANALYSIS IDENTIFIED THERE WAS FLUID WAS LEAKING FROM THE TIP AT 16 ATMOSPHERES. THERE WAS A PINHOLE IN THE PROXIMAL TAPER OF THE BALLOON AND A TEAR NOTED IN THE INNER MEMBER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10708737 ↗
• InjuryOct 31, 2019Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 75% STENOSED, MODERATELY TORTUOUS, AND MILDLY CALCIFIED DE NOVO LESION IN THE POSTERIOR TIBIAL ARTERY. A 2.0X30MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) MET RESISTANCE WITH THE ANATOMY DURING REMOVAL AND THE TIP OF THE BDC ALONG WITH THE MARKERS WERE SEPARATED. A SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE SEPARATED BALLOON. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9262710 ↗