TREK™ 1012276-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648138591), received between Jun 20, 2018 and Feb 22, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2019Deflation Problem; Difficult to Remove; Material Separation; Deflation Problem; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY. A 3.5X25MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INSTRUCTIONS FOR USE WITH A CONTRAST MIX OF 50/50. THE BDC WAS USED FOR PRE-DILATATION AND INFLATED THREE TIMES AT 12 ATMOSPHERES FOR 12 SECONDS. THE BALLOON WOULD NOT DEFLATE COMPLETELY AND WAS REMOVED PARTIALLY INFLATED. RESISTANCE WITH THE ANATOMY AND GUIDING CATHETER WAS FELT DURING REMOVAL. THE BDC, GUIDE WIRE, AND GUIDE CATHETER ALL HAD TO BE REMOVED TOGETHER; HOWEVER, DURING THIS THE SHAFT OF THE BDC BROKE INSIDE THE GUIDING 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 8363570 ↗
• InjuryJun 20, 2018Detachment Of Device Component; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY (RCA). DURING UNPACKING OF THE FIRST TREK BALLOON DILATATION CATHETER (BDC) , IT WAS NOTED THAT THERE WAS A KINK IN THE DISPENSER HOOP COIL. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE PROXIMAL SHAFT WAS KINKED/BENT. ANOTHER BALLOON WAS USED TO CONTINUE THE PROCEDURE. HOWEVER, THE PHYSICIAN DEEMED IT NECESSARY TO UPSIZE ON THE BDC. ANOTHER TREK BDC WAS USED AND ADVANCED TO THE LESION WITH NO RESISTANCE. IT WAS INFLATED ONCE AT NOMINAL PRESSURE. DURING DEFLATING, IT WAS NOTED THAT THE BALLOON WOULD NOT DEFLATE AT ALL. THE INDEFLATOR WAS THEN REMOVED AND A SYRINGE WAS USED TO PULL NEGATIVE FOR 20 SECONDS MULTIPLE TIMES. BLOOD WAS PRESENT IN THE SYRINGE. IT WAS THOUGHT THAT THE BALLOON HAD RUPTURED. HOWEVER, THROUGH A SECOND CHECK, THE BALLOON WAS STILL FULLY INFLATED. THE PHYSICIAN THEN DECIDED TO REMOVE THE BALLOON (FULLY INFLATED), WHEN THE DISTAL SHAFT BROKE OFF AND THE BALLOON REMAINED IN THE RCA. RESISTANCE WAS FELT WITH THE HI-TORQUE WIGGLE GUIDE WIRE (GW) DURING THE REMOVAL OF THE BDC WHEN THE SHAFT BROKE. TWO NON-ABBOTT GW WERE THEN USED IN AN ATTEMPT TO POKE AND RUPTURE THE BALLO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7621907 ↗