TREK™ 1012280-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648138775), received between Feb 21, 2017 and Jul 20, 2022 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (6 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.

• MalfunctionJul 20, 2022Difficult 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 AN ANTERIOR INTERVENTRICULAR ARTERY. A NON-ABBOTT GUIDE WIRE WAS INSERTED INTO THE ANATOMY AND THEN THE 5.0X12 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED. THE BALLOON WAS INFLATED TO 12-14 ATMOSPHERES AN UNKNOWN NUMBER OF TIMES. NEGATIVE PRESSURE WAS HELD FOR 3 SECONDS AND THE BALLOON COMPLETELY DEFLATED AT THE LESION. UPON REMOVAL, THE BALLOON SEPARATED FROM THE CATHETER AND CAUGHT ON THE NON-ABBOTT GUIDE WIRE. THE BDC AND GUIDE WIRE WERE REMOVED AS THE BALLOON WAS ATTACHED TO THE GUIDE WIRE. THERE WAS A 15 MINUTE DELAY IN THE PROCEDURE; HOWEVER THERE WAS NO HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065082 ↗
• InjuryMay 17, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY WITH SLIGHT ANEURYSM ALTERED WITH RELATIVE, SLIGHT STENOSIS TO THE OUTLET AND COMPLETE THROMBOSIS WITH SUBACUTE OCCLUSION. A 5X12MM TREK BALLOON WAS ADVANCED AND INFLATED AT THE THREE TIMES AT 10 ATMOSPHERES WITHOUT ISSUE. THE BALLOON WAS COMPLETELY DEFLATED. HOWEVER DURING WITHDRAWAL OF THE DEVICE, THE BALLOON PORTION BECAME DETACHED FROM THE CATHETER SHAFT AND REMAINED IN THE PATIENT. THE PATIENT WAS TRANSFERRED TO CARDIAC SURGERY AND AORTO-CORONARY VEIN BYPASS GRAFTING WAS PERFORMED AND THE BALLOON WAS SUCCESSFULLY REMOVED. PATIENT STATUS IS VERY GOOD, AS OPERATION WAS UNCOMPLICATED AND PATIENT WAS DISCHARGED FROM THE CLINIC AFTER A WEEK. THERE WAS A CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14416192 ↗
• MalfunctionMay 9, 2022Deflation Problem; Off-Label Use; Deflation Problem; Off-Label Use

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT RENAL ARTERY WITH NO REPORTED CALCIFICATION OR TORTUOSITY AND THERE WAS AN OLD STENT PRESENT IN THE ANATOMY THAT MAY HAVE BEEN UNDER-DEPLOYED. THE 5.0X12 MM TREK BALLOON DILATATION CATHETER (BDC) WAS PREPPED PER THE INSTRUCTIONS FOR USE AND THE CONTRAST MIX WAS STANDARD. THE TREK BDC WAS BEING USED TO DILATE THE OLD STENT. THE TREK BDC WAS INFLATED TO 14 ATMOSPHERES (ATM) MULTIPLE TIMES FROM 6 TO 14 ATM; HOWEVER, THE BALLOON WAS SLOW TO DEFLATE. THE DEFLATION TOOK MUCH LONGER THAN USUAL; HOWEVER THE TIME WAS NOT RECORDED. THE BALLOON ULTIMATELY DID FULLY DEFLATE AND THERE WAS NO DIFFICULTY REMOVING THE TREK BDC. A DIFFERENT ABBOTT PERIPHERAL BALLOON WAS USED LATER IN THE CASE WITH NO ISSUES. THERE WERE NO 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 14337788 ↗
• MalfunctionMar 25, 2022Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT MAIN CORONARY ARTERY WITH NO TORTUOSITY. THE 5.00X12 MM TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE AT 14 ATMOSPHERES FOR 20 SECONDS. THE CONTRAST MIX WAS 50/50 AND THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE SHEATH. AT THE TIME OF DEFLATION, THERE WAS RESISTANCE WHEN ATTEMPTING TO RETRIEVE THE BALLOON THROUGH THE GUIDING CATHETER AND FORCE WAS APPLIED. THE BALLOON WAS PARTIALLY DEFLATED. THE PHYSICIAN WAITED 10 SECONDS FOR THE BALLOON TO DEFLATE AND THE BALLOON SEPARATED INTO 3 PIECES. THE GUIDING CATHETER AND THREE GUIDE WIRES THAT WERE PRESENT IN THE ANATOMY WERE REMOVED IN ORDER TO REMOVE THE TREK AS A WHOLE AND ALL THREE PIECES WERE REMOVED. IT WAS CONFIRMED THAT NO PORTION REMAINED IN THE PATIENT. THERE WERE NO ADVERSE PATIENT EFFECTS. THE PROCEDURE WAS EXTENDED FOR 10 MINUTES BUT THERE WAS NO INJURY TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13903752 ↗
• InjuryOct 16, 2020Deflation Problem; Difficult to Remove; Material Separation; Deflation Problem; Difficult to Remove; Material Separation

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT MAIN CORONARY ARTERY COMMON TRUNK. A 5X12MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE, AND THE BALLOON WAS INFLATED ONCE TO NOMINAL PRESSURE. HOWEVER, THE BALLOON COMPLETELY FAILED TO DEFLATE, SO THE INFLATED BALLOON WAS BEING REMOVED WHEN IT FACED RESISTANCE DURING REMOVAL WITH AN UNSPECIFIED 014 GUIDE WIRE. THE BDC SHAFT SEPARATED INTO TWO PIECES, AND A DISSECTION WAS NOTED. UNSPECIFIED DEVICES WERE ATTEMPTED TO TREAT THE DISSECTION BUT FAILED, SO THE PATIENT WAS SENT TO SURGERY TO REMOVE THE SEPARATED PORTION AND RESOLVE THE DISSECTION. THE PATIENT THEN HAD BYPASS SURGERY AND IS DOING FINE NOW. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 10693116 ↗
• InjuryOct 5, 2020Deflation Problem; Difficult to Remove; Material Separation; Deflation Problem; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT DURING AN ANEURYSM REPAIR PROCEDURE, THE TREK RX WAS ADVANCED AND INFLATED. A GUIDE LINER WAS ADVANCED OVER THE BALLOON. ATTEMPTS WERE MADE TO DEFLATE THE BALLOON, BUT IT FAILED TO DEFLATE. SOME TROUBLE SHOOTING WAS PERFORMED, BUT THE BALLOON STILL COULD NOT BE DEFLATED. DURING REMOVAL OF THE INFLATED BALLOON, IT WAS PULLED INTO THE GUIDE CATHETER, BUT BROKE MID-SHAFT. THE SEPARATED PORTION WAS SNARED AND PULLED INTO THE GUIDE CATHETER, BUT THE SHAFT BROKE AGAIN. ALL PARTS OF THE SEPARATED DEVICE WERE REMOVED, EXCEPT FOR THE BALLOON PORTION WITH THE MARKERS. AFTER A SURGICAL CONSULT THE SEPARATED INFLATED BALLOON WITH MARKERS WAS LEFT IN THE ANEURYSM THAT WAS GOING TO BE OCCLUDED. THE PATIENT REMAINED STABLE AND REMAINED HOSPITALIZED FOR ANOTHER DAY FOR MONITORING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10627330 ↗
• InjuryJul 7, 2020Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RENAL STENOSIS WITH BALLOON ANGIOPLASTY ONLY. THE 5.00X12 MM TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED MULTIPLE TIMES, 8 ATM FOR 15 SECONDS, 14 ATM FOR 20 AND 30 AND 15 SECONDS. THERE WERE NO ISSUES WITH INFLATION OR DEFLATION OF THE BALLOON; HOWEVER, IT WAS NOT NOTED HOW LONG NEGATIVE PRESSURE WAS HELD BEFORE ATTEMPTING REMOVAL OF THE BDC. DURING REMOVAL OF THE TREK BDC, RESISTANCE WAS FELT WITH THE GUIDING CATHETER AND IT CAUSED A PORTION OF THE BALLOON TO SHEAR OFF. SNARE WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE PORTION REMAINS IN THE PATIENT. THE PATIENT IS DOING FINE AND WAS DISCHARGED. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10240250 ↗
• MalfunctionFeb 21, 2017Detachment Of Device Component; Difficult to Remove

  IT WAS REPORTED THAT A 5.0X12MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS UNPACKAGED AND PREPPED WITHOUT ISSUE. THE TREK RX BDC WAS THEN ADVANCED WITHOUT RESISTANCE TO A LESION IN THE SAPHENOUS VEIN GRAFT (SVG) TO THE RIGHT CORONARY ARTERY (RCA) AND DILATATION WAS SUCCESSFULLY COMPLETED. THE TREK RX BDC WAS THEN RETRACTED WITHOUT DIFFICULTY FROM THE ANATOMY AND THROUGH THE GUIDING CATHETER, HOWEVER, DURING RETRACTION THROUGH THE NON-ABBOTT HEMOSTATIC VALVE, RESISTANCE WAS FELT AGAINST THE VALVE AND THE ENTIRE TREK RX BALLOON DETACHED (SEPARATED) FROM THE DISTAL SHAFT AT THE PROXIMAL BALLOON SEAL. AS THE SEPARATED PIECE WAS LOCATED OUTSIDE OF THE VALVE, IT WAS SIMPLY WITHDRAWN FROM THE VALVE. 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 6345625 ↗