TREK™ 1012273-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648138362), received between May 2, 2017 and Jun 4, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING LESION WITH 99% STENOSIS. A 2.75X15 MM TREK 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. HOWEVER, RESISTANCE WAS NOTED DURING ADVANCEMENT. DURING THE FIRST INFLATION AT 6 ATM, THE BALLOON RUPTURED. 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 25395167 ↗
• MalfunctionNov 21, 2025Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED CORONARY ARTERY. THE 2.75X15 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE INFLATED; HOWEVER, THE BALLOON DID NOT INFLATE AND THERE WAS BACK FLOW OF BLOOD INTO THE INFLATOR [RUPTURE]. UPON REMOVAL OF THE DEVICE FROM THE GUIDING CATHETER, THE HYPOTUBE BECAME SEPARATED. THE GUIDING CATHETER WAS REMOVED AND THE SEPARATED PIECES WERE RECOVERED. A NEW GUIDING CATHETER AND BALLOON WERE 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 23616771 ↗
• MalfunctionDec 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS AND 90% STENOSED PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH THE 2.75X15MM TREK BALLOON DILATATION CATHETER (BDC) WHICH WAS PREPARED PER INSTRUCTIONS FOR USE. THE BDC WAS ADVANCED AND THE BALLOON WAS INFLATED ONCE TO 8 ATMOSPHERES WHEN A RUPTURE OCCURRED AFTER 5 SECONDS. THEREFORE, BALLOON ANGIOPLASTY WAS ATTEMPTED WITH A 3.00X15MM NC TREK NEO BDC; HOWEVER, WHEN THE BALLOON WAS INFLATED ONCE TO 10 ATMOSPHERES, A RUPTURE OCCURRED AFTER 5 SECONDS. ADDITIONAL DILATATION WAS PERFORMED WITH A NON-ABBOTT ROTABLATION DEVICE AND ANOTHER NC TREK BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO 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 20836406 ↗
• MalfunctionJul 3, 2024Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THE 2.75 X 15MM TREK RX WAS TO BE USED IN THE MID LEFT ANTERIOR DESCENDING (MLAD) LESION WITH RESISTANCE DUE TO THE HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE TREK BALLOON WAS USED FOR PRE-DILATATION, HOWEVER, THE BALLOON RUPTURED AT 15 ATMOSPHERES (ATMS) WHICH IS ABOVE THE RATED BURST PRESSURE (RBP) DURING THE SECOND INFLATION. THEREFORE, THE BALLOON WAS REMOVED AND ANOTHER TREK RX 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 19670262 ↗
• MalfunctionJun 24, 2024Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A TORTUOUS AND CALCIFIED LESION IN THE ANTERIOR DESCENDING BRANCH. RESISTANCE WAS MET WITH THE ANATOMY DURING ADVANCEMENT OF THE 2.75X15MM RX TREK BALLOON DILATATION CATHETER (BDC) AND THE SHAFT BROKE; HOWEVER WAS NOT IN TWO PIECES. THE DEVICE WAS SIMPLY WITHDRAWN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594046 ↗
• MalfunctionSep 7, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BOX OF A 2.75X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS OPENED FOR USE WHEN THE BDC INSIDE THE BOX WAS ACTUALLY A 2.75X12MM (1012273-12 / LOT: 10809G1). THE BDC WAS THE INCORRECT SIZE AND WAS NOT USED FOR 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 15374413 ↗
• MalfunctionSep 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH 90% STENOSIS, MILD CALCIFICATION, AND NO TORTUOSITY. THE 2.75X15MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS USED FOR PRE-DILATATION BUT RUPTURED WHEN IT WAS INFLATED ONCE AT 12 ATMOSPHERES (ATMS) FOR 10 SECONDS. THERE WAS NO RESISTANCE DURING ADVANCEMENT. THE BALLOON WAS SOAKED IN SALINE AND WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO RESISTANCE WHEN THE PROTECTIVE SHEATH WAS REMOVED. THERE WAS NO RESISTANCE DURING REMOVAL. ANOTHER SAME SIZE NON-ABBOTT 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 15362914 ↗
• MalfunctionSep 28, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MILDLY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 2.75X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE, AND THE BALLOON RUPTURED DURING THE THIRD INFLATION AT 12 ATMOSPHERES. AN UNSPECIFIED BALLOON AND UNSPECIFIED XIENCE STENT WERE 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 12541248 ↗
• MalfunctionApr 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN IN-STENT RESTENOSIS. THE 2.75X15 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE NOTED AND RUPTURED AT 6 ATMOSPHERES. A NON-ABBOTT BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9928976 ↗
• MalfunctionOct 15, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LEFT ANTERIOR DESCENDING ARTERY THAT WAS 90% STENOSED. THE 2.75X15MM RX TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. THE BALLOON RUPTURED AT AN UNSPECIFIED PRESSURE. A NEW 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 Consequences Or Impact To Patient

  MAUDE report 9192414 ↗
• MalfunctionFeb 15, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-TORTUOUS, MILDLY CALCIFIED MID TO DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 2.75 X 15MM TREK BALLOON DILATATION CATHETER (BDC) RUPTURED WHEN INFLATED TO 6 ATMOSPHERES. ANOTHER BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7274982 ↗
• MalfunctionMay 2, 2017Material Rupture; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED, MODERATELY TORTUOUS, AND HEAVILY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING PRE-DILATATION WITH A NON-ABBOTT BALLOON, A 2.75X15MM TREK RX BALLOON DILATATION CATHETER MET RESISTANCE WITH THE LESION DURING ADVANCEMENT. ONCE AT THE LESION SITE THE BALLOON RUPTURED DURING FIRST INFLATION AT 12 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 2.75X15MM NON-ABBOTT BALLOON CATHETER AND NON-ABBOTT STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6538974 ↗