MINI TREK™ 1012402-08ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648180811), received between Nov 9, 2018 and Aug 6, 2024 — classified as 8 malfunctions.

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

• MalfunctionAug 6, 2024Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN A UNKNOWN VESSEL. REPORTEDLY DILATATION OF THE VESSEL WAS PERFORMED USING A 1.50X8MM MINI TREK II BALLOON DILATATION CATHETER (BDC); HOWEVER, IT WAS NOTED THAT THE GUIDEWIRE IN USE GOT STUCK WHEN BEING REMOVED FROM THE BDC. DUE TO THE RESISTANCE DURING REMOVAL THE BDC WAS NOTED TO HAVE A SLIGHT CURVE. ANOTHER DILATATION CATHETER WAS USED AND THE PROCEDURE WAS COMPLETED. 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 19916609 ↗
• MalfunctionMay 16, 2024Product Quality Problem; Component Misassembled; Product Quality Problem; Component Misassembled

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED DE NOVO LESION IN THE 1ST DIAGONAL ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 1.5X8MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE; HOWEVER, ONE PART OF THE CENTER MARKER APPEARED TO BE ON THE TIP OF THE BDC. THE BDC WAS USED IN THE PROCEDURE WITHOUT ISSUE. 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 19334034 ↗
• MalfunctionFeb 20, 2024Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method; Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE 1.5X8MM MINI TREK II BALLOON DILATATION CATHETER RUPTURED AT 5 ATMOSPHERES IN THE MARSHAL VEIN. ANOTHER UNSPECIFIED BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. SUBSEQUENT TO THE INITIALLY FILED REPORT, IT WAS ALSO NOTED THAT THE BALLOON WAS INFLATED DURING PREPARATION OF THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743732 ↗
• MalfunctionJan 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT POSTERIOR DESCENDING CORONARY ARTERY THAT WAS MODERATELY CALCIFIED AND HEAVILY TORTUOUS. THE MINI TREK II OTW 1.50 X 8 MM, BALLOON DILATATION CATHETER CROSSED A CHRONIC TOTAL OCCLUSION LESION, BUT A RUPTURE OCCURRED DURING THE FIRST INFLATION AT NOMINAL PRESSURE. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO REPORT OF CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18467147 ↗
• MalfunctionJan 2, 2024Off-Label Use; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Split, Cut or Torn; Off-Label Use; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE BRAIN. THE 1.5X8 MM MINI TREK BALLOON DILATATION CATHETERS (BDC) BECAME STUCK WITH THE GUIDE WIRE AND THE BALLOON AND GUIDE WIRE WERE REMOVED TOGETHER. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18430648 ↗
• MalfunctionJan 2, 2024Off-Label Use; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Split, Cut or Torn; Off-Label Use; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE BRAIN. THE 1.5X8 MM MINI TREK BALLOON DILATATION CATHETERS (BDC) BECAME STUCK WITH THE GUIDE WIRE AND THE BALLOON AND GUIDE WIRE WERE REMOVED TOGETHER. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18430384 ↗
• MalfunctionJan 14, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONICALLY TOTALLY OCCLUDED LEFT ANTERIOR DESCENDING ARTERY. THE PATIENT WAS TREATED WITH A GUIDE WIRE THAT CROSSED TO THE LESION ANTEGRADELY, THEN A NON-ABBOTT 1.0 MM BALLOON DILATATION CATHETER CROSSED THE LESION. AFTER THAT, A MINI TREK II (OTW) BALLOON WAS ATTEMPTED TO BE ADVANCED BUT FAILED TO CROSS DUE TO THE ANATOMY. DURING REMOVAL, RESISTANCE WITH ANATOMY WAS ALSO MET. A NEW NON-ABBOTT 1.5 MM BALLOON DILATATION CATHETER (RX) WAS REPLACED TO CONTINUE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11174505 ↗
• MalfunctionNov 9, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED OBTUSE MARGINAL ARTERY. DURING REMOVAL OF A 1.5X8MM MINI TREK BALLOON DILATATION CATHETER, IT GOT STUCK ON A FIELDER XT GUIDE WIRE (GW) AND THE COATING OF THE CORE AND TIP OF THE GW PEELED OFF INSIDE THE GUIDE WIRE LUMEN OF THE BALLOON CATHETER. THE DEVICES WERE SIMPLY REMOVED AS A SINGLE UNIT. 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 8057335 ↗