TREK™ 1012276-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648138607), received between Nov 2, 2017 and Feb 23, 2026 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Difficult to Remove; Material Separation

  SUBSEQUENT TO THE INITIAL REPORT BEING FILED, A MEDWATCH REPORT WAS RECEIVED STATING THE FOLLOWING: DURING PCI (PERCUTANEOUS CORONARY INTERVENTION), AS PTCA (PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY) BALLOON WAS BEING REMOVED FROM LAD (LEFT ANTERIOR DESCENDING), BALLOON SHAFT BROKE WITH THE BALLOON AT END OF GUIDE. DR (B)(6) REMOVED GUIDE, BALLOON, AND WIRE AS ONE UNIT SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416586 ↗
• MalfunctionAug 29, 2025Difficult to Remove; Material Separation; Failure to Deflate; Difficult to Remove; Material Separation; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MID RIGHT CORONARY ARTERY. THE 3.5X30MM TREK BALLOON DILATATION CATHETER WAS USED AT THE BEGINNING OF THE CASE INFLATED TO 14 ATMOSPHERES FOR THREE TIMES. LATER IT WAS RE-INSERTED AND INFLATED; HOWEVER, THE BALLOON WOULD NOT DEFLATE AFTER INFLATION. NUMEROUS ATTEMPTING TO DEFLATE THE BALLOON WERE ATTEMPTED INCLUDING EXCHANGING THE INFLATION DEVICE; HOWEVER, FAILED. THE BDC WAS MOVED BACK TO MOUTH OF THE GUIDING CATHETER DISENGAGING IT FROM THE RCA AND INTENTIONALLY OVER-INFLATING THE BALLOON PAST THE RATED BURST PRESSURE UNTIL IT RUPTURED IN THE AORTA. THE BALLOON, GUIDE WIRE AND GUIDE CATHETER WERE ALL REMOVED THROUGH THE SHEATH. A PROCEDURE WAS COMPLETED WITH XIENCE STENT AND NC TREK NEO BALLOONS. THERE WAS 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 22927322 ↗
• MalfunctionJul 1, 2025Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A 3.50X30MM TREK RX BALLOON DILATATION CATHETER WAS USED OVER AN UNSPECIFIED BMW GUIDEWIRE. DURING PRE-DILATION, THE TREK RX BALLOON WAS INFLATED AT 12 ATMOSPHERES FOR 20 SECONDS. THE TREK RX BALLOON COULD NOT BE COMPLETELY DEFLATED EVEN AFTER FOUR ATTEMPTS. DURING REMOVAL, THE INFLATED TREK RX BALLOON MET RESISTANCE WITH ANATOMY AND WAS REMOVED WITH FORCE. AN UNSPECIFIED DEVICE WAS USED TO 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 22374996 ↗
• MalfunctionDec 5, 2024Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.50X30MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR PRE-DILATATION OF THE LESION. AFTER THE FIRST INFLATION THE BDC WAS REMOVED WITHOUT ISSUE. THE BDC WAS RE-INSERTED LATER IN THE PROCEDURE AND INFLATED HOWEVER THE BALLOON WOULD NOT DEFLATE. RESISTANCE WAS MET DURING RETRACTION WITH THE GUIDE WIRE AND GUIDING CATHETER THEREFORE ALL THE DEVICES WERE REMOVED AS A SYSTEM. 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 20852258 ↗
• InjuryNov 5, 2024Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  A MED SUN UF/IMPORTER REPORT WAS RECEIVED WHICH REPORTED THE FOLLOWING REGARDING A TREK BALLOON DILATATION CATHETER: "DURING A PLANNED, STAGED HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (PCI), A STENT BALLOON BROKE OFF AND BECAME CAUGHT ON THE STRUT OF THE STENT DISRUPTING BLOOD FLOW TO THE CORONARY ARTERY. ATTEMPTS TO RETRIEVE IT WERE UNSUCCESSFUL AND CV SURGERY WAS CONSULTED, BUT DECLINED TO TAKE THE PATIENT TO THE OR EMERGENTLY DUE TO HIS CO-MORBIDITIES AND BEING FULLY ANTI COAGULATED. THE PATIENT WAS RETURNED TO THE CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU) IN CRITICAL CONDITION WITH AN IMPELLA IN PLACE FOR SUPPORT. THE WIRE/DEVICE PACKAGING WAS INADVERTENTLY THROWN AWAY SO WE ARE UNABLE TO SEQUESTER THE PRODUCT." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 20615579 ↗
• InjuryJul 30, 2024Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AND THE CIRCUMFLEX CORONARY ARTERY. TWO NON-ABBOTT STENTS WERE IMPLANTED. THE PROCEDURE WAS CONTINUED WITH A 3.50 X 30 MM TREK BALLOON DILATATION CATHETER (BDC) AND A 4.0X15 MM TREK BDC USING THE KISSING BALLOON TECHNIQUE. THE 4.0X15 MM TREK BDC WAS REMOVED WITH NO ISSUES. HOWEVER, THERE WAS RESISTANCE FELT DURING REMOVAL OF THE 3.5X30 MM TREK BDC AND SOME FORCE WAS BRIEFLY APPLIED. ONCE THE BDC WAS REMOVED IT WAS NOTED THAT THE BALLOON HAD BROKEN OFF FROM THE SHAFT AREA. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND FOUND THAT THE BALLOON HAD SEPARATED AND REMAINED STUCK ON THE PREVIOUSLY IMPLANTED STENT IN THE PATIENT ANATOMY. A SNARE WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE PATIENT WAS TRANSFERRED TO ICU AND SURGERY WAS PERFORMED ON (B)(6) 2024. THE PATIENT IS STABLE IN THE INTENSIVE CARE UNIT AS OF 07/17/2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19865115 ↗
• MalfunctionApr 7, 2022Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH GOOD SIZE, NO CALCIFICATION, NO STENOSIS, NO TORTUOSITY. A NON-ABBOTT GUIDE CATHETER CAUSED A DISSECTION WHICH ALSO CAUSED CARDIOGENIC SHOCK. THE PATIENT'S BLOOD PRESSURE DROPPED AND HAD CHEST PAIN. THIS ARTERY HAD TO BE TREATED BECAUSE IT WAS COMPLETELY DISSECTED WITH THE DIAGNOSTIC PROBE. A NON-ABBOTT GUIDE WIRE CROSSED THE LESION AND 3 XIENCE SKYPOINT STENTS WERE SUCCESSFULLY IMPLANTED. THE 3.5X30MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS SUCCESSFULLY USED FOR POST-DILATATION AND INFLATED 4 TIMES TO 8, 8, 10 AND 14 ATMOSPHERES (ATMS). AFTER FINISHING INFLATION THE BALLOON WAS DEFLATED IMMEDIATELY AND KEPT DEFLATED WITH NEGATIVE PRESSURE. THE STENTS WERE CONFIRMED TO BE WELL APPOSED TO THE VESSEL WALL. HOWEVER, THE BALLOON DID NOT MOVE UPON ATTEMPTED REMOVAL AND ONLY THE HYPOTUBE WAS REMOVED. THE BALLOON PART GOT STUCK ON THE GUIDE WIRE. THE GUIDE WIRE, REMAINING PART OF THE BALLOON AND THE GUIDE CATHETER WERE ALL REMOVED AS A UNIT. NO DEVICE REMAINED STUCK IN THE PATIENT ANATOMY. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT DUE TO THE TREK BDC AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047045 ↗
• MalfunctionNov 19, 2021Deflation Problem; Difficult to Remove; Material Separation; Deflation Problem; Difficult to Remove; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE MILDLY TORTUOUS, MILDLY CALCIFIED DISTAL RIGHT CORONARY ARTERY. THE 3.5 X 30 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATATION WITHOUT ISSUE. IT WAS INFLATED A COUPLE OF TIME BETWEEN 12-14 ATMOSPHERES. DURING REMOVAL, THE BDC GOT STUCK IN THE GUIDE CATHETER AND THE BALLOON DETACHED INSIDE THE GUIDE CATHETER. ALL THE DEVICES WERE REMOVED TOGETHER, INCLUDING THE DETACHED BALLOON INSIDE OF THE GUIDE CATHETER. IT WAS SUSPECTED THE BALLOON DID NOT FULLY DEFLATE RESULTING IN THE DIFFICULT REMOVAL. AN UNSPECIFIED STENT WAS IMPLANTED, COMPLETING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849462 ↗
• InjuryJun 16, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE 100% STENOSED MID RIGHT CORONARY ARTERY. A 3.5X30MM TREK BALLOON DILATATION CATHETER WAS INFLATED ONCE AT 16 ATMOSPHERES, AND A PERFORATION WAS NOTED AFTER ITS USE. FOUR NON-ABBOTT COVERED STENTS WERE USED AS TREATMENT, AND THE PATIENT WAS DISCHARGED ON (B)(6)2020. THE PATIENT RETURNED ON (B)(6) 2020 WITH SYNCOPE, BUT THERE WAS NO TREATMENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2020 AND THE PATIENT IS IN GOOD CONDITION. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation; Syncope

  MAUDE report 10159815 ↗
• InjuryMar 2, 2020Deflation Problem; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY TORTUOUS LESION IN THE CIRCUMFLEX ARTERY (CX). THE PATIENT PRESENTED WITH AN INFERIOR ST-ELEVATION MYOCARDIAL INFARCTION AND STENT THROMBOSIS IN AN ANOMALOUS CX. THE PATIENT HAD MULTIPLE LAYERS OF STENT AND A FULL METAL JACKET IN THE CX. PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED SMALL SIZE BALLOON AND GOOD FLOW WAS ACHIEVED. A COMMENT WAS MADE DURING INITIAL INFLATIONS THAT IT WAS DIFFICULT TO SEE THE BALLOON INFLATE, AND A REQUEST TO INCREASE THE CONTRAST MIX WAS MADE, HOWEVER IT REMAINED AT 50:50 CONCENTRATION. A 3.5X30MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS INFLATED TO 18 ATMOSPHERES WITH NO CONCERNS. AFTER USE, AN ATTEMPT TO DEFLATE THE BALLOON WAS MADE; HOWEVER, IT WOULD NOT DEFLATE, AND DOUBLE NEGATIVE WAS PERFORMED. THE BDC WAS GENTLY PULLED AND THE SHAFT SEPARATED FROM THE BALLOON. THE SEPARATED BALLOON REMAINED IN THE OSTIUM OF THE CX. A TRAPPING BALLOON WAS USED TO ATTEMPT AND REMOVE THE SEPARATED BALLOON, BUT THE BALLOON WOULD NOT DISLODGE. AN UNSPECIFIED 1.5MM BALLOON WAS ABLE TO PASS BELOW THE INFLATED BALLOON, GENTLY INFLATED, AND WAS ABLE TO DISLODGE THE SEPARATED BALLOON. AGAIN, A TRA

  Patient problems: Angina; Non specific EKG/ECG Changes

  MAUDE report 9776114 ↗
• InjuryNov 2, 2017Detachment Of Device Component; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PATIENT HAD A PROCEDURE PERFORMED ON (B)(6) TO TREAT A LESION IN A PULMONARY VESSEL WITH A 3.5 X 30 MM RX TREK BALLOON CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CONSEQUENCES NOTED. HOWEVER, FIVE MONTHS LATER (B)(6), THE PATIENT EXPERIENCED DYSPNEA. TIME-DIVISION MULTIPLEXING (TDM) IMAGING [FLUOROSCOPY] WAS PERFORMED AND IT WAS OBSERVED THAT THE DISTAL PART OF THE TREK BALLOON CATHETER HAD SEPARATED AND WAS LEFT IN THE PULMONARY ARTERY AT THE TIME OF PROCEDURE ON (B)(6). THE SEPARATED DISTAL SECTION OF THE DEVICE WAS RETRIEVED SUCCESSFULLY WITH A LASSO TECHNIQUE AND NO SURGERY WAS REQUIRED. AFTER, THE PATIENTS CONDITION WAS FINE AND NO TREATMENT WAS NEEDED FOR THE DYSPNEA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Foreign Body In Patient

  MAUDE report 6997535 ↗