TREK™ 1012278-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648138706), received between Jul 27, 2020 and Apr 12, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionApr 12, 2024Device Misassembled During Manufacturing /Shipping; Material Split, Cut or Torn; Device Misassembled During Manufacturing /Shipping; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION, THE 4.0X12 MM TREK BALLOON DILATATION CATHETER (BDC) WAS REMOVED FROM THE DISPENSER HOOP AND IT WAS NOTED THAT THE HYPOTUBE HAD BEEN PUNCTURED BY THE STYLET WHICH WAS OUT OF PLACE IN THE PACKAGING. ANOTHER 4.0X12 MM TREK BDC WAS REMOVED FROM THE DISPENSER HOOP WHEN THE SAME ISSUE WAS NOTED. THE OUTER PACKAGING OF BOTH DEVICES WAS NOT DAMAGED. THE DEVICES WERE NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW, SAME SIZE TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19097369 ↗
• InjuryOct 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL RAMUS INTERVENTRICULARIS ANTERIOR (RIVA) ARTERY. THE 4.0X12MM TREK CORONARY DILATATION CATHETER (CDC) WAS USED SUCCESSFULLY, BUT DURING REMOVAL, THE BALLOON DETACHED FROM THE CATHETER. THERE WAS NO RESISTANCE DURING ADVANCEMENT OR REMOVAL OF THE CDC. THE SEPARATED BALLOON WAS REMOVED WITH A SNARE DEVICE. THERE WERE NO FURTHER COMPLICATIONS. THE PATIENT IS DOING WELL. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916567 ↗
• InjuryOct 12, 2022Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MID RIGHT CORONARY ARTERY. FOR POST-DILATATION, A TREK BALLOON WAS INSERTED AND ADVANCED TO THE LESION. UNSPECIFIED NUMBER OF INFLATIONS WERE PERFORMED. DURING REMOVAL, SOME RESISTANCE WITH AN UNSPECIFIED SOURCE WAS MET AND THE SHAFT SEPARATED, REMAINING IN THE ANATOMY. ANOTHER NC TREK BALLOON WAS ADVANCED IN AN ATTEMPT TO RETRIEVE THE SEPARATED SHAFT OF THE FIRST BALLOON. HOWEVER, DURING ATTEMPTED REMOVAL, THE NC TREK SHAFT ALSO SEPARATED, ALTHOUGH NO RESISTANCE WAS MET. A 3RD UNSPECIFIED BALLOON WAS USED AND ADVANCED PAST THE TWO SEPARATED PORTIONS, INFLATED AND PULLED THE SEPARATED SHAFTS OUT OF THE PATIENT ANATOMY. NOTHING REMAINS IN THE PATIENT. THE PROCEDURE CONCLUDED AT THIS POINT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591259 ↗
• InjurySep 28, 2021Deflation Problem; Difficult to Remove; Material Separation; Deflation Problem; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH MYOCARDIAL INFARCTION. ANGIOGRAPHY NOTED THAT THE MID RIGHT CORONARY ARTERY (RCA) WAS 100% OCCLUDED WITH CLOT, AND THE RCA OSTIUM WAS 99% OCCLUDED. A NON-ABBOTT GUIDE CATHETER EXTENSION WAS USED. STENTING WAS PERFORMED USING NON-ABBOTT STENTS. THE 4.0 X 12 MM TREK DILATATION CATHETER WAS ADVANCED FOR POST DILATATION OF A NON-ABBOTT STENT. THE BALLOON WAS INFLATED WITHOUT ISSUE AND WAS THOUGHT TO BE DEFLATED WITHOUT ISSUE. AN ATTEMPT WAS MADE TO REMOVE THE TREK DILATATION CATHETER; HOWEVER, IT WAS NOTED THAT THE BALLOON REMAINED PARTIALLY INFLATED AND SEPARATED IN THE ANATOMY. IT IS UNKNOWN WHAT CAUSED THE BALLOON SEPARATION; HOWEVER, IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE GUIDE CATHETER EXTENSION WAS REMOVED, SOME OF THE NON-ABBOTT STENT STRUTS BECAME FLARED. AN ATTEMPT WAS MADE TO REMOVE THE BALLOON; HOWEVER, THIS WAS UNSUCCESSFUL. THE PLAN WAS MADE TO POSSIBLY SEND THE PATIENT FOR SURGICAL INTERVENTION. THE PATIENT WAS TRANSFERRED TO HIS ROOM AND WAS IN STABLE CONDITION. THERE WAS GOOD BLOOD FLOW AROUND THE SEPARATED BALLOON SEGMENT. THE PATIENT WILL UNDERGO CATHETERIZATION ON (B)(6) 2021, AND THE DECISION WILL BE MA

  Patient problems: Foreign Body In Patient

  MAUDE report 12544321 ↗
• InjuryJul 27, 2020Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY. THE 4.0X12MM TREK BALLOON FAILED TO INFLATE. THERE WAS A LEAK FROM THE SHAFT ABOUT 3 TO 4 CM FROM THE BALLOON. CONTRAST MEDIA BUBBLES WERE RELEASED INTO THE LEFT MAIN ARTERY. 24 HOURS AFTER THE PROCEDURE, AN ST-ELEVATION OCCURRED ON THE ECG. THE PATIENT HAD CHEST PAIN THAT LASTED FOR SEVERAL HOURS THEN STOPPED. TREATMENT, IF ANY, WAS NOT REPORTED. A CLINICALLY SIGNIFICANT DELAY WAS REPORTED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Air Embolism; Angina; Non specific EKG/ECG Changes

  MAUDE report 10327018 ↗