MINI TREK™ 1012403-08ARecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08717648180866), received between May 31, 2017 and Aug 21, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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.

• MalfunctionAug 21, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 2X8MM MINI TREK II OTW BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION AT 6 ATMOSPHERES (ATM). 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 22866496 ↗
• MalfunctionDec 16, 2024Inflation Problem; Off-Label Use; Material Rupture; Inflation Problem; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE VEIN OF MARSHALL. A 2.0X8MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND ATTEMPTED TO BE INFLATED; HOWEVER THE BALLOON WAS NOTED TO BE RUPTURED DURING ITS FIRST INFLATION TO 8ATM. THE MINI TREK BDC WAS REPLACED WITH ANOTHER BDC AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE DEVICE WAS RECEIVED AND THE QAT ANALYSIS COULD NOT CONFIRM THE BALLOON RUPTURE; HOWEVER, NOTED A LEAK IN THE HUB. THE ACCOUNT CONFIRMED THAT NO RUPTURE WAS NOTED ON THE BALLOON, AND INSTEAD THEY WERE REPORTING THAT THE BDC WAS UNABLE TO BE INFLATED. NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20939804 ↗
• MalfunctionJul 16, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE PROCEDURE THE BALLOON OF THE 2X8MM MINI TREK II BALLOON DILATATION CATHETER (BDC) WAS PIERCED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER BALLOON WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19756697 ↗
• MalfunctionJun 21, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN A UNSPECIFIED ARTERY. THE 2X6MM MINI TREK II BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED IN THE PROCEDURE; HOWEVER, A LEAK WAS NOTED BETWEEN THE INTERNAL LUMEN AND THE BALLOON LUMEN. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19588227 ↗
• MalfunctionApr 16, 2024Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT PRIOR TO USE OF THREE 2.0X8MM MINI TREK II BALLOON DILATATION CATHETERS THE BALLOON WAS INFLATED OUTSIDE THE ANATOMY TO 6 ATMOSPHERES AND RUPTURED. A NEW DEVICE 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 19117282 ↗
• MalfunctionApr 16, 2024Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT PRIOR TO USE OF THREE 2.0X8MM MINI TREK II BALLOON DILATATION CATHETERS THE BALLOON WAS INFLATED OUTSIDE THE ANATOMY TO 6 ATMOSPHERES AND RUPTURED. A NEW DEVICE 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 19117204 ↗
• MalfunctionApr 16, 2024Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT PRIOR TO USE OF THREE 2.0X8MM MINI TREK II BALLOON DILATATION CATHETERS THE BALLOON WAS INFLATED OUTSIDE THE ANATOMY TO 6 ATMOSPHERES AND RUPTURED. A NEW DEVICE 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 19117162 ↗
• MalfunctionFeb 2, 2024Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method; Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, THE BALLOON RUPTURED DURING THE 1ST INFLATION AT 8 ATMOSPHERES. THE HOSPITAL CONTACT STATED THAT THE PREP INSTRUCTIONS WERE FOLLOWED ACCORDING TO THE INSTRUCTIONS FOR USE, HOWEVER AN INFLATION TEST WAS DONE DURING PREP AND THE BALLOON WAS SOAKED IN WATER IN ORDER TO VERIFY THAT THE BALLOON CAN BE USED WITH ETHANOL FOR VEIN OF MARSHALL ETHANOL INFUSION. 2017- INCORRECT PREP CODING ADDED SINCE THEY INFLATED THE BALLOON DURING PREP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636443 ↗
• MalfunctionSep 28, 2023Inflation Problem; Leak/Splash; Off-Label Use; Inflation Problem; Leak/Splash; Off-Label Use

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MARSHALL VEIN. DURING INJECTION OF LIQUID IN THE 2.0X8 MM MINI TREK BALLOON DILATATION CATHETER, THERE WAS A LEAK NOTED FROM A HOLE LOCATED AT THE CONNECTION/HUB AREA OF THE DEVICE. THIS WAS PREVENTING BALLOON INFLATION. ANOTHER UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS A DELAY IN THE PROCEDURE; HOWEVER, THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17839797 ↗
• MalfunctionApr 14, 2023Off-Label Use; Material Split, Cut or Torn; Off-Label Use; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A FIBRILLATION ABLATION PROCEDURE IN THE MARSHALL VEIN, THE 2.00X8MM MINI TREK II BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE APPROPRIATE PLACE AND INFLATED WHEN AN UNSPECIFIED 0.014 GUIDE WIRE PIERCED THE BALLOON. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. ANOTHER SAME SIZE MINIT TREK BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16747966 ↗
• MalfunctionApr 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED DURING PREPARATION OF THE 2.0X8MM MINI TREK BALLOON DILATATION CATHETER (BDC) THE BALLOON RUPTURED AT 8 ATMOSPHERES. THE DEVICE WAS NOT USED AND ANOTHER BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14250694 ↗
• MalfunctionJun 3, 2021Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. A 2X8MM MINI TREK II BALLOON DILATATION CATHETER (BDC) FACED RESISTANCE DURING ADVANCEMENT AND REMOVAL WITH A NON-ABBOTT GUIDE WIRE, AND THE SHAFT WAS NOTED TO BE KINKED. AN UNSPECIFIED DEVICE 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 11935503 ↗
• MalfunctionMay 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY. THE MINI TREK BALLOON WAS ADVANCED WITHOUT ISSUE TO THE LESION AND RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT BALLOON DILATATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10067932 ↗
• MalfunctionMay 31, 2017Material Rupture; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CONCENTRIC, HEAVILY CALCIFIED, 99% STENOSED LESION IN THE MILDLY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). A 2.0X8MM MINI TREK II OTW BALLOON DILATATION CATHETER (BDC) WAS UNPACKAGED AND PREPPED OUTSIDE OF PATIENT ANATOMY WITHOUT ISSUE. THE BDC WAS THEN ADVANCED OVER A NON-ABBOTT GUIDE WIRE, INTO A NON-ABBOTT GUIDING CATHETER AND TO THE LESION, WITH RESISTANCE FELT AGAINST THE PROXIMAL PART OF THE LESION; TAPPING TECHNIQUE WAS USED TO FACILITATE CROSSING OF THE LESION. DURING INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES. THE BDC WAS WITHDRAWN WITHOUT RESISTANCE. AN ATTEMPT WAS THEN MADE TO PERFORM DILATATION WITH A NON-ABBOTT BALLOON, BUT THIS BALLOON ALSO RUPTURED. THE RESULTING STENOSIS WAS 75% AND NO FURTHER ATTEMPTS WERE MADE TO TREAT THE LESION AS FURTHER DILATATION OF THIS LESION IS CONSIDERED IMPOSSIBLE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6603456 ↗