TREK 1012405-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648153983), received between Aug 3, 2016 and Mar 13, 2024 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED. THE 2.5X15 MM TREK OTW BALLOON DILATATION CATHETER (BDC) WAS USED TO TREAT THE LESION. DURING REMOVAL, THE SHAFT SEPARATED AND A SNARE WAS USED TO SUCCESSFULLY REMOVE THE DEVICE. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OR WITHDRAWAL. IT WAS NOTED THAT THE SEPARATION MAY HAVE BEEN DUE TO THE PATIENT ANATOMY AS IT WAS SEVERELY CALCIFIED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899298 ↗
• MalfunctionJun 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS DISTAL LEFT ANTERIOR DESCENDING ARTERY. A 2.5X15MM TREK BALLOON CROSS THE LESION. WHEN INFLATED ONCE AT 12 ATMOSPHERES THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND REPLACED WITH A NON-ABBOTT DEVICE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14654976 ↗
• MalfunctionAug 3, 2017Material Rupture; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, ECCENTRIC AND MODERATELY CALCIFIED DE NOVO DISTAL LEFT ANTERIOR DESCENDING ARTERY THAT WAS 99% STENOSED. A SION GUIDE WIRE WAS CROSSED AND THEN A 2.5 X 15 MM TREK OTW BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION; HOWEVER, RESISTANCE WAS FELT AGAINST THE TORTUOUS VESSEL AND LESION. THE BALLOON WAS INFLATED ONCE AND IT RUPTURED AT 6 ATMOSPHERES. IT WAS THEREFORE REPLACED WITH A NON-ABBOTT BALLOON CATHETER TO PRE-DILATE THE LESION AND IMPLANT A XIENCE ALPINE STENT TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6765799 ↗
• MalfunctionApr 21, 2017Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). AFTER ADVANCING A HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II 300CM GUIDE WIRE (GW) PAST THE LESION WITHOUT DIFFICULTY, A 2.5X15MM TREK OTW BALLOON DILATATION CATHETER (BDC) WAS UNPACKAGED AND PREPPED WITHOUT ISSUE AND WAS ADVANCED OVER THE GW AND TO THE LESION WITHOUT RESISTANCE. THE LESION WAS SUCCESSFULLY PRE-DILATED WITH THE TREK OTW BDC, HOWEVER, AFTER DEFLATION, WITHOUT DIFFICULTY, THE BDC WAS VERY DIFFICULT TO RETRACT OVER THE GW. AS THE PHYSICIAN DID NOT WANT TO LOSE LESION POSITIONING BY WITHDRAWING BOTH DEVICES AS A SINGLE UNIT, THE TREK OTW BDC WAS RETRACTED OVER THE GW AGAINST RESISTANCE. WITH THE SAME GW STILL IN PLACE, A NON-ABBOTT STENT SYSTEM WAS ADVANCED, THE STENT WAS DEPLOYED, AND THE SYSTEM WAS WITHDRAWN OVER THE GW WITHOUT RESISTANCE. WHILE A HALF-HOUR DELAY OCCURRED, IT DID NOT RESULT IN A HEALTH IMPACT. THERE WERE NO ADVERSE EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6511896 ↗
• MalfunctionNov 29, 2016Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT A CONCENTRIC, HEAVILY CALCIFIED, 90% STENOSED, 3.0X28MM, DE NOVO LESION IN THE MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, AFTER UNPACKAGING THE DEVICE WITHOUT ISSUE AND AFTER PREPPING THE DEVICE VIA AIR ASPIRATION INSIDE OF PATIENT ANATOMY, THE 2.5X15MM TREK OTW BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 7 ATMOSPHERES (ATM) AT 1 SECOND. THE BDC WAS WITHDRAWN WITHOUT RESISTANCE. THE DEVICE WAS REPLACED WITH AN NC TREK 2.5X15MM BDC. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER A XIENCE ALPINE 3.0X28MM STENT WAS IMPLANTED, RESULTING IN 0% LESION STENOSIS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6133666 ↗
• MalfunctionAug 3, 2016Unsealed Device Packaging

  IT WAS REPORTED DURING UNPACKING OF THE OTW 2.5 X 15 MM TREK BALLOON DILATATION CATHETER, THE VENDOR SEAL OF THE POUCH WAS ALREADY OPENED. THEREFORE, THE DEVICE WAS NOT USED. ANOTHER TREK BALLOON WAS USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5845294 ↗