TREK™ 1012274-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648138454), received between Sep 21, 2017 and Dec 7, 2022 — classified as 1 death, 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2022Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE OBTUSE MARGINAL CORONARY ARTERY WITH MILD TORTUOSITY, MODERATE CALCIFICATION AND IN STENT RESTENOSIS. THE PATIENT HAD SIGNIFICANT 3 VESSEL DISEASE BUT THEY WERE NOT A CANDIDATE FOR BYPASS SURGERY. THE 3.0X25 MM TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE AND DEFLATED AFTER USE BUT DURING REMOVAL THE BALLOON WAS LODGED AT THE MOUTH OF THE GUIDING CATHETER. THE BALLOON SEPARATED INTO TWO PIECES. THE BALLOON REMAINED ON THE GUIDE WIRE. THE BALLOON AND THE CATHETER OF THE DEVICE WERE REMOVED WITH THE GUIDE WIRE AND GUIDE CATHETER AS A SINGLE UNIT. THERE WAS NO REPLACEMENT DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT EXPIRED WITHIN 24 HOURS OF (B)(6) 2022; HOWEVER THE CAUSE OF DEATH WAS NOT PROVIDED AND IN THE PHYSICIAN'S OPINION, THE TREK BALLOON DID NOT CAUSE OR CONTRIBUTE TO THE DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15934845 ↗
• InjuryAug 18, 2022Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, 50-70% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3X25MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATATION AND INFLATED ONE TIME TO 20 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. SOME OF THE BALLOON PIECES WERE SNARED FROM THE ANATOMY AND OTHER PIECES COULD NOT BE SNARED AND WERE STENTED IN PLACE IN THE ANATOMY. AFTER THE PROCEDURE THE PATIENT SEEMED FINE AND WAS DISCHARGED FROM THE HOSPITAL THAT SAME DAY. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15255484 ↗
• MalfunctionJul 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN INTERVENTION, THE 3.0X25MM TREK RX BALLOON RUPTURED IN THE PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14989011 ↗
• InjuryJul 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). THE PATIENT HAD MULTIPLE LESIONS AND A PREVIOUS PERCUTANEOUS CORONARY INTERVENTION (PCI). THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS. A 3X25MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION, HOWEVER WHEN INFLATION WAS INITIATED, THE BALLOON RUPTURED AT UNKNOWN ATMOSPHERES (ATM) AND THE PATIENT CODED DUE TO AN AIR EMBOLIZATION. DEFIBRILLATION AND MEDICATIONS WERE USED TO STABILIZE THE PATIENT, FOLLOWED BY THE IMPLANTATION OF THREE UNSPECIFIED STENTS IN THE RCA. SUBSEQUENTLY A 2.5X20MM TREK BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Air Embolism; Cardiac Arrest

  MAUDE report 14988753 ↗
• MalfunctionJul 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE 100% STENOSED LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE PATIENT PRESENTED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI). THE 3.0X25 MM TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE AND RUPTURED. A 3.0X20 MM BALLOON WAS USED AT 14 ATMOSPHERES (ATM), FOLLOWED BY A 4.0X15 MM NON COMPLIANT (NC) BALLOON, THEN A 3.5X20 MM TREK BDC TO TREAT THE LESION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS 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 14977016 ↗
• MalfunctionFeb 26, 2020Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Advance; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2020, A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED WITHIN THE RIGHT CORONARY ARTERY (RCA), HEAVILY CALCIFIED LESION. A TREK DILATATION CATHETER ADVANCED WITH UNUSUAL RESISTANCE FELT DUE TO ANATOMY. INFLATION WAS PERFORMED TO 16 ATMOSPHERES WHEN THE BALLOON RUPTURED. DURING TREK REMOVAL, UNUSUAL RESISTANCE WAS FELT WITH ANATOMY AND THE SHAFT SEPARATED INTO TWO PIECES. ALL WAS REMOVED AS A SINGLE UNIT AND NOTHING FROM THE DEVICE WAS LEFT IN THE ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9753602 ↗
• MalfunctionAug 20, 2019Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A 3.00 X 25 MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPPED INSIDE THE DISPENSER HOOP. ON REMOVAL FROM THE DISPENSER HOOP WITH NO RESISTANCE, THE SHAFT OF THE BDC WAS NOTED TO BE BENT JUST DISTAL TO THE HYPOTUBE. THE SHAFT THEN SEPARATED AT THE SITE OF THE BEND. THERE WAS NO REPORTED DAMAGE NOTED TO THE DISPENSER HOOP AND THERE WAS NO PATIENT INVOLVEMENT. A NEW UNSPECIFIED TREK BDC WAS USED TO CONTINUE THE PROCEDURE AND AN UNSPECIFIED XIENCE SIERRA STENT WAS DEPLOYED WITH NO REPORTED ISSUES. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8913331 ↗
• DeathSep 21, 2017Detachment Of Device Component; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT PRESENTED (B)(6) 2017 WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI), AND DECLINING HEALTH TOWARD DEATH. AFTER PLACEMENT OF A BALLOON PUMP AND A PACEMAKER, ANGIOGRAPHY REVEALED A LEFT MAIN STUMP ONLY; BOTH THE LEFT ANTERIOR DESCENDING (LAD) AND THE CIRCUMFLEX (CX) WERE OCCLUDED WITH THROMBUS. AFTER PLACEMENT OF A 6FR NON-ABBOTT GUIDING CATHETER (GC), A WHISPER GUIDE WIRE (GW) WAS ADVANCED TO THE LAD WITHOUT DIFFICULTY AND A NON-ABBOTT GW WAS ADVANCED TO THE CX. THE LEFT MAIN (LM) WAS DILATED WITH A 3.0X18MM NON-ABBOTT BALLOON, THEN THE BALLOON WAS WITHDRAWN. A 3.0X25MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS THEN ADVANCED TO THE MILDLY CALCIFIED, NON-TORTUOUS LAD WITHOUT RESISTANCE. THE TREK RX WAS INFLATED TWICE TO 14 ATMOSPHERE (ATM); ONCE IN THE MID AND ONCE IN THE PROXIMAL LAD; HOWEVER, THE BDC FAILED TO DEFLATE. SLIGHT RESISTANCE WAS FELT AGAINST THE VESSEL WHEN SLIGHT FORCE WAS APPLIED WHILE PULLING NEGATIVE PRESSURE TO RETRACT THE TREK RX BALLOON BACK INTO THE GC. THE GC, TREK RX BDC, WHISPER GW, AND OTHER NON-ABBOTT GW WERE ALL REMOVED AS A SINGLE UNIT FROM THE ANATOMY (BLOOD WAS NOTED IN THE INDEFLATOR AND AIR WAS NOTED IN THE GC). AF

  Patient problems: Cardiac Arrest; Death

  MAUDE report 6883609 ↗