TREK™ 1012279-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648138751), received between Nov 16, 2017 and Aug 14, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2025Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN OSTIAL RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 4.5X12MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED TO NOMINAL PRESSURE; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AND PIECE OF THE BALLOON SEPARATED. A STENT WAS IMPLANTED TO EMBED THE SEPARATED PIECE OF BALLOON. THE STENT WAS POST DILATED WITH A NC TREK NEO BALLOON TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22809597 ↗
• InjuryJan 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. AFTER A STENT WAS DEPLOYED AT THE TARGET LESION, A 4.5X12MM NC TREK BALLOON DILATATION CATHETER WAS USED FOR POST DILATATION AND INFLATED TWICE TO 9ATM AND 12ATM; HOWEVER, AFTER THE BALLOON WAS FULLY DEFLATED, THE BALLOON WAS NOTED TO SEPARATE IN THE VESSEL DURING REMOVAL. THE SEPARATED BALLOON WAS REMOVED BY UTILIZING A GUIDELINER AND ANOTHER TREK BALLOON TO TRAP THE DISLODGED BALLOON INTO THE GUIDELINER WHERE IT WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21248497 ↗
• MalfunctionJun 13, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE BIFURCATION OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND DIAGONAL ARTERY. THE 4.5X12MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS BEING PREPARED WHEN THE INDEFLATOR WAS PUT ON NEGATIVE PRESSURE, THE INDEFLATOR JUST FILLED WITH AIR SUGGESTING A HOLE IN THE BALLOON. ANOTHER 4.5X15MM TREK RX BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533954 ↗
• MalfunctionNov 16, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. REPORTEDLY, TWO 4.5 X 12 MM TREK BALLOONS RUPTURED AT 8 ATMOSPHERES (ATMS) DURING THE 1ST INFLATION. THERE HAD BEEN NO RESISTANCE NOTED DURING ADVANCEMENT OF THE TREK BALLOON CATHETERS. 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 7037649 ↗
• MalfunctionNov 16, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. REPORTEDLY, TWO 4.5 X 12 MM TREK BALLOONS RUPTURED AT 8 ATMOSPHERES (ATMS) DURING THE 1ST INFLATION. THERE HAD BEEN NO RESISTANCE NOTED DURING ADVANCEMENT OF THE TREK BALLOON CATHETERS. 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 7037643 ↗