TREK™ 1012275-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648138492), received between Mar 20, 2019 and Jul 19, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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.

• MalfunctionJul 19, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 3.25X12MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BDC FAILED TO CROSS IT. THEREFORE, THE BDC WAS REMOVED AND RESISTANCE WAS ALSO NOTED WITH THE LESION. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 17351717 ↗
• InjuryDec 2, 2020Difficult to Remove; Material Rupture; Material Separation; Difficult to Advance; Difficult to Remove; Material Rupture; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN OCCLUDED LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD), LEFT MAIN (LM) AND LEFT CIRCUMFLEX CORONARY (LCX) ARTERIES. A 3.0X33MM XIENCE SIERRA STENT WAS IMPLANTED IN THE LCX. KISSING BALLOON WAS THEN TO BE PERFORMED. A 3.25X12MM TREK BALLOON WAS ADVANCED WITH SLIGHT RESISTANCE INTO THE LCX. WHEN THE 3.5X12MM TREK BALLOON WAS PLACED IN THE LM/PLAD, THERE WAS SLIGHT MOVEMENT OF THE BALLOON IN THE LCX. AN ATTEMPT WAS MADE TO REMOVE THE BALLOON FROM THE LCX, BUT IT WAS STUCK. TROUBLE SHOOTING WAS PERFORMED AND THE BALLOON WAS REMOVED WITH RESISTANCE, AND ONCE REMOVED, IT WAS NOTED THAT THE BALLOON WAS TORN AND THE LCX WAS OCCLUDED. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED AND A PIECE OF BALLOON WAS NOTED ATTACHED TO THE 3.0X33MM XIENCE SIERRA STENT IN THE LCX. THE PIECE OF THE BALLOON WAS NOT ABLE TO BE REMOVED AND REMAINS IN THE PATIENT. THE PATIENT EXPERIENCED AN ACUTE MYOCARDIAL INFARCTION AND ACUTE LUNG EDEMA AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND PLACED EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism; Myocardial Infarction; Pulmonary Edema

  MAUDE report 10932260 ↗
• InjuryDec 11, 2019Fracture; Difficult to Remove

  DURING PTCA PROCEDURE OF MID LEFT CIRCUMFLEX ARTERY THE BALLOON FRACTURED AND BECAME ENTRAPPED WITHIN CALCIFIED VESSEL. BALLOON WAS UNABLE TO BE RETRIEVED SO DECISION WAS MADE TO ABORT AND MONITOR PT CLOSELY IN CCU. PT EXPERIENCE NO UNTOWARD SYMPTOMS DURING STAY OR UP TO THIS WRITING. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9458553 ↗
• InjuryDec 6, 2019Entrapment of Device; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Entrapment of Device; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED CIRCUMFLEX LESION. A 3.25X12MM RX TREK BALLOON RUPTURED AT 18 ATMOSPHERES ON THE SECOND INFLATION. THE BALLOON DILATATION CATHETER (BDC) MET RESISTANCE WITH THE ANATOMY DURING RETRIEVAL AND THE BALLOON SEPARATED IN THE ANATOMY. AN ATTEMPT WAS MADE TO RETRIEVE THE SEPARATED BALLOON USING AN UNSPECIFIED GUIDE LINER BUT WAS UNSUCCESSFUL AND THE BALLOON WAS LEFT IN THE VESSEL. ALTHOUGH THE VESSEL WAS TOTALLY OCCLUDED, TREATMENT WAS NOT DONE AS THE VESSEL HAD COLLATERALS TO THE AREA FROM OTHER VESSELS. ONCE THE RX TREK BECAME STUCK IN THE VESSEL, IT CONTRIBUTED TO THE BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDEWIRE AND A NON-ABBOTT GUIDEWIRE TO LOSE DISTAL ACCESS. THE GUIDE WIRE WAS REPLACED WITH A WIGGLE WIRE GUIDEWIRE. PER THE ACCOUNT, THERE WAS NO ISSUE WITH THE BMW. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Occlusion; Vessel Or Plaque, Device Embedded In

  MAUDE report 9432803 ↗
• MalfunctionMar 20, 2019Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ECCENTRIC LESION IN THE MILDLY TORTUOUS, MILDLY CALCIFIED, 99% STENOSED DISTAL RIGHT CORONARY ARTERY. A 3.25X12M TREK RX BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE PRIOR TO USE, BUT PREPPED (AIR ASPIRATION) INSIDE THE ANATOMY. RESISTANCE WAS FELT WHEN REMOVING THE PROTECTIVE SHEATH. THE BDC WAS ADVANCED TO THE LESION WITHOUT RESISTANCE, AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 5 ATMOSPHERES FOR 5 SECONDS. THE BDC WAS REMOVED WITHOUT RESISTANCE AND REPLACED WITH A SAME SIZE TREK RX 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 Consequences Or Impact To Patient

  MAUDE report 8436633 ↗