TREK™ 1012273-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648138355), received between Jul 11, 2018 and Jul 26, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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.

• MalfunctionJul 26, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 100% STENOSED DE NOVO LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (DLAD) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 2.75X12MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY AND THE BALLOON WAS INFLATED; HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER TREK BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS 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 19843683 ↗
• MalfunctionOct 2, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 2.75X12MM TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR PRE-DILATATION, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 10 ATMOSPHERES. RESISTANCE DURING ADVANCEMENT OF THE BDC WAS NOTED WITH ANATOMY. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17854085 ↗
• MalfunctionJan 17, 2022Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED AND CONCENTRIC LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE 2.75X12 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE WITH THE ANATOMY AND WAS INFLATED ONCE TO 6 ATMOSPHERES AND RUPTURED. THERE WAS RESISTANCE WITH THE ANATOMY NOTED DURING INDEPENDENT REMOVAL. A NEW TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266842 ↗
• MalfunctionJul 23, 2021Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.75X12MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INSTRUCTIONS FOR USE. THE BDC WAS ADVANCED; HOWEVER, RESISTANCE WITH THE ANATOMY WAS FELT. ONCE AT THE TARGET LESION, THE BALLOON RUPTURED AT NOMINAL PRESSURE DURING FIRST INFLATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED DEVICE. 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 12221883 ↗
• MalfunctionJul 8, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING UNPACKING OF A 2.75X12MM TREK BALLOON DILATATION CATHETER (BDC), THE CONNECTION PIECE OF THE HUB WAS FOUND TO BE BROKEN OFF. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10244787 ↗
• MalfunctionJul 8, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 2.75X12MM RX TREK BALLOON RUPTURED DURING USE. A NEW TREK BALLOON 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 Consequences Or Impact To Patient

  MAUDE report 8767419 ↗
• MalfunctionAug 31, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN ECCENTRIC DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH NO TORTUOSITY, MILD CALCIFICATION AND 90% STENOSIS. A 2.75X12 MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR PRE-DILATATION WITH NO RESISTANCE. THE BALLOON OF THE BDC RUPTURED ON THE FIRST INFLATION AT 6 ATMOSPHERES. AN ADDITIONAL NON-ABBOTT BDC WAS USED SUCCESSFULLY 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 Consequences Or Impact To Patient

  MAUDE report 7839840 ↗
• MalfunctionJul 11, 2018Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CONCENTRIC LESION IN THE DISTAL RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY THAT WAS 90% STENOSED. DILATATION WAS PERFORMED USING A 2.75 X 12 MM TREK BALLOON CATHETER. ALTHOUGH RESISTANCE WAS MET WITH THE ANATOMY DURING ADVANCEMENT, THE BALLOON CATHETER REACHED THE TARGET LESION. THEN AFTER THE BALLOON WAS INFLATED ONE TIME, IT RUPTURED AT APPROXIMATELY 10 ATMOSPHERES. THE BALLOON CATHETER WAS REMOVED AND A NON-ABBOTT BALLOON CATHETER WAS USED TO COMPLETE DILATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED DRUG-COATED BALLOON CATHETER. 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 7678904 ↗