TREK™ 1012271-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648138232), received between Jan 16, 2020 and May 12, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 99% STENOSIS. THE 2.25X20 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES AND RUPTURED. ANOTHER TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149004 ↗
• MalfunctionMar 25, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE TORTUOSITY AND SEVERE CALCIFICATION. FOR PRE-DILATION, THE 2.25 X 20 MM TREK BALLOON DILATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO 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. THE PROCEDURE WAS CONTINUED WITH ANOTHER TREK BDC. 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 24695325 ↗
• MalfunctionMay 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AFTER REMOVING THE 2.25X20MM TREK BALLOON DILATATION CATHETER (BDC) FROM THE DISPENSER HOOP, THE BALLOON WAS NOTED TO HAVE SEPARATED FROM THE SHAFT OF THE BDC. THEREFORE, THE BDC WAS NO USE IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19222847 ↗
• InjuryMay 3, 2023Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH MODERATE CALCIFICATION. THE 2.25X20MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS SOAKED AND PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO RESISTANCE DURING ADVANCEMENT. THE BALLOON WAS USED FOR PRE-DILATATION OF THE PROXIMAL LAD AND WAS INFLATED ONCE AT A PRESSURE OF 12 ATMOSPHERES (ATMS) FOR 7 SECONDS. A STENT WAS THEN IMPLANTED AND THE SAME TREK RX BALLOON WAS ADVANCED WITHOUT RESISTANCE FOR A SECOND INFLATION ATTEMPT FOR PRE-DILATATION OF THE MID LAD AT 14 ATMS FOR 14 SECONDS. HOWEVER, WHEN THE BALLOON WAS INFLATED, THE PATIENT BECAME HYPOTENSIVE AND BRADYCARDIC AND WENT INTO CARDIAC ARREST SUSPECTING THAT AN AIR EMBOLISM OCCURRED DUE TO A POSSIBLE BALLOON RUPTURE AND THE PATIENT CODED. AN IMPELLA DEVICE WAS USED. THE WHOLE SYSTEM WAS REMOVED TOGETHER WITH THE GUIDING CATHETER AND NOTHING WAS LEFT IN THE PATIENT. UPON REMOVAL, IT WAS NOTED THAT THE TIP INCLUDING THE DISTAL MARKER SHEARED OFF AND SEPARATED. THE PATIENT IS STILL IN THE HOSPITAL BUT NO LONGER WITH THE IMPELLA DEVICE. IT HAS BEEN CONFIRMED THE PATIENT WAS DISCHARGED. NO ADDITI

  Patient problems: Air Embolism; Bradycardia; Cardiac Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 16864998 ↗
• MalfunctionDec 18, 2021Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.25X20 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE ANATOMY AND WAS USED FOR PRE-DILATATION BUT THE BALLOON RUPTURED UPON THE FIRST INFLATION AT 10 ATMOSPHERES. A NON-ABBOTT BALLOON 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13040082 ↗
• MalfunctionJan 21, 2020Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT DURING ADVANCEMENT OF THE 2.25X20 MM TREK RX THROUGH THE GUIDE CATHETER, THE TREK MET RESISTANCE AND THE SHAFT OF THE TREK SEPARATED IN TWO PIECES IN THE GUIDE CATHETER. THE GUIDE CATHETER AND THE SEPARATED TREK WERE REMOVED TOGETHER AS A UNIT. THE SAME GUIDE CATHETER WAS USED WITH ANOTHER SAME SIZE TREK TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9610909 ↗
• MalfunctionJan 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED LESION, IN THE RIGHT CORONARY ARTERY. THE 2.25X20MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATATION AND DURING THE THIRD INFLATION, THE BALLOON RUPTURED, POSSIBLY DUE TO THE CALCIFICATION. THE BDC WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT BDC. 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 9597513 ↗