TREK™ 1012272-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648138317), received between May 23, 2017 and Jul 11, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ONCE THE 2.5X25MM TREK BALLOON DILATATION CATHETER WAS REMOVED FROM THE CHIPBOARD BOX THE DEVICE INSIDE THE BOX WAS ACTUALLY A 2.5X12MM TREK BALLOON. ANOTHER 2.5X25MM TREK BALLOON WAS OPENED AND 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 19723657 ↗
• InjuryApr 20, 2020Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY TORTUOUS AND RESTENOSED LESION IN THE CIRCUMFLEX ARTERY. THE PATIENT PRESENTED WITH NON-ST SEGMENT ELEVATION MYOCARDIAL INFRACTION. A 2.5X25MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER NORMAL PROCEDURE. THE BDC WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON DID NOT INFLATE. THE BDC WAS REMOVED TO ACCESS THE ISSUE. AT THIS POINT, THE PATIENTS PRESSURE BEGAN DROPPING RAPIDLY. ANOTHER ANGIO WAS TAKEN AND IT WAS NOTICED THAT THE LEFT MARGINAL ARTERY BECAME OCCLUDED. THE PATIENT ARRESTED. MORE HEPARIN WAS GIVEN AND THE PATIENT WAS RECOVERED USING CARDIOPULMONARY RESUSCITATION. FLOW WAS RESTORED AND THE PROCEDURE WAS QUICKLY COMPLETED. FOLLOWING THE PROCEDURE, THE BDC WAS INVESTIGATED AND IT IS BELIEVED THAT THERE MAY HAVE BEEN A SLOW LEAK, WHICH COLLECTED ATMOSPHERIC AIR UPON PREPARATION, WHICH SUBSEQUENTLY CAUSED AN AIR EMBOLISM. THE BDC WAS TESTED UNDER WATER AND A LEAK ON THE SHAFT WAS NOTED. THERE WERE NO ADVERSE PATIENT SEQUELA AND A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Air Embolism; Cardiac Arrest; Occlusion

  MAUDE report 9978396 ↗
• InjuryMar 25, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. IT WAS NOTED THAT DURING INFLATION OF A 2.5X25MM TREK BALLOON THE TIP AND BALLOON BECAME SEPARATED. THE BALLOON WAS SIMPLY REMOVED BUT IT IS UNKNOWN IF THE TIP WAS RETRIEVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9877985 ↗
• MalfunctionMay 23, 2017Detachment Of Device Component

  IT WAS REPORTED THAT DURING UNPACKAGING, WHILE REMOVING A 2.5X25MM TREK RX BALLOON DILATATION CATHETER (BDC) FROM ITS DISPENSER HOOP PACKAGING WITHOUT DIFFICULTY, THE HYPOTUBE SHAFT REPORTEDLY SNAPPED IN HALF (SEPARATED). THERE WAS NO DAMAGE NOTED TO ANY OF THE PACKAGING MATERIALS. THE DEVICE WAS NOT USED IN THE PATIENT AND THIS ISSUE DID NOT CAUSE OR CONTRIBUTE TO ANY CLINICALLY SIGNIFICANT DELAY. ANOTHER TREK RX BDC WAS UNPACKAGED AND USED WITHOUT ISSUE TO PERFORM THE PLANNED PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6585931 ↗