TREK™ 1012274-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648138416), received between Sep 23, 2016 and Jan 31, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (3 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.

• MalfunctionJan 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 3.0X8MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS NOTED TO HAVE BROKEN [RUPTURED] DURING THE PROCEDURE PRESENTING THE PATIENT WITH A RISK OF GAS EMBOLISM. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT 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 16271918 ↗
• InjuryDec 23, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY TORTUOSITY IN THE CIRCUMFLEX ARTERY. A 3.0 X 8 MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE AND USED FOR POST STENT DILATATION. THE BDC WAS THEN REMOVED WITHOUT ANY RESISTANCE; HOWEVER, IT WAS OBSERVED THAT THE RADIOPAQUE BALLOON MARKER HAD COME OFF THE BDC AND BECAME STUCK ON THE IMPLANTED STENT. THE BALLOON MARKER WAS NOT RETRIEVED FROM THE PATIENT'S ANATOMY. NO DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11067478 ↗
• MalfunctionAug 22, 2019Inflation Problem; Leak/Splash; Material Rupture; Inflation Problem; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT A 3.0X8MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS BEING PREPARED PER THE INSTRUCTIONS FOR USE; HOWEVER, A LEAK WAS NOTED DURING AN ATTEMPT TO PULL NEGATIVE PRESSURE. PRESSURE WAS APPLIED AND THE LEAK WAS CONFIRMED. THE BDC WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 3.0X8MM TREK BALLOON DILATATION CATHETER. 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 8922531 ↗
• MalfunctionAug 20, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MODERATELY TORTUOUS, MODERATELY CALCIFIED RIGHT CORONARY ARTERY. DURING PREP, NEGATIVE WAS PULLED ON A 3X8MM TREK BALLOON DILATATION CATHETER (BDC), AND THE DEVICE WAS NOTED TO BE LEAKING. THEN, THE BALLOON WAS ATTEMPTED TO BE INFLATED BUT FAILED TO DO SO. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW SAME SIZE TREK BDC 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 Patient Involvement

  MAUDE report 8912918 ↗
• MalfunctionFeb 22, 2019Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE 3.0X8 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE HEAVILY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY, BUT WAS UNABLE TO BE INFLATED TO 12 ATMOSPHERES. THE INFLATION DEVICE WOULD NOT HOLD PRESSURE AND A BALLOON RUPTURE WAS SUSPECTED, BUT A RUPTURE WAS NOT VISIBLE ON FLUOROSCOPY. THE TREK BALLOON WAS NOT SEEN EXPANDING DURING ATTEMPTS TO INFLATE IT. THE TREK WAS REMOVED AND A NON-ABBOTT BDC WAS USED WITHOUT FURTHER INCIDENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8363310 ↗
• MalfunctionOct 3, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION, WHEN THE TREK RX 3.0 X 8 MM BALLOON DILATATION WAS LOADED ONTO THE GUIDE WIRE, THE PROXIMAL SHAFT BROKE APART AND SPLIT IN TWO PIECES OUTSIDE THE PATIENT. THERE WAS NO REPORTED RESISTANCE FELT. THE DEVICE WAS NOT USED AND A NEW SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. 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 7932050 ↗
• MalfunctionSep 23, 2016Detachment Of Device Component; Kinked

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE POSTERIOR DESCENDING ARTERY WITH MILD TORTUOSITY AND MILD CALCIFICATION. A 3X8MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS INSERTED INTO AN UNSPECIFIED GUIDE CATHETER, THE MID SHAFT KINKED. THE PHYSICIAN WITHDREW THE BDC AND THE MID SHAFT SEPARATED. REPORTEDLY THERE WAS NO RESISTANCE NOTED DURING ADVANCEMENT OR WITHDRAWAL. BOTH PIECES WERE SIMPLY WITHDRAWN FROM THE GUIDE CATHETER. AN UNSPECIFIED BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5975200 ↗