TREK™ 1012272-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648138324), received between Feb 26, 2019 and Feb 26, 2025 — classified as 3 injuries, 12 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2025Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DIAGONAL ARTERY. THE 2.5X30MM TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED IN THE PROCEDURE; HOWEVER, THE BALLOON BECAME TORN AND SEPARATED WHILE INTRODUCING THE BALLOON IN THE GUIDE CATHETER. THE BDC AND SEPARATED PORTION WAS ABLE TO BE REMOVED FROM THE PATIENT. ANOTHER TREK BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21473778 ↗
• InjuryAug 16, 2023Off-Label Use; Material Separation; Off-Label Use; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PERONEAL ARTERY IN THE LOWER LEG WITH STENOSIS. THE 2.5X30MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS BEING ADVANCED WHEN THE DELIVERY CATHETER BROKE INTO TWO PIECES. A SNARE DEVICE WAS USED TO RETRIEVE THE SEPARATED PORTION AND NOTHING WAS LEFT INSIDE THE ANATOMY. IT WAS AT THE END OF THE PROCEDURE WHEN THE DEVICE SEPARATED AND THE PROCEDURE ENDED WITHOUT USING ANOTHER BALLOON OR DEVICE THERE WAS NO REPORTED ADVERSE PATIENT SEQUELAE AND 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 17557535 ↗
• MalfunctionJul 7, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS BOTH MODERATELY TORTUOUS AND CALCIFIED. THE TREK RX 2.50 X 30MM BALLOON DILATATION CATHETER (BDC) FAILED TO CROSS THE LESION. THERE WAS ALSO RESISTANCE WITH THE LESION DURING REMOVAL OF THE BDC. A NON-ABBOTT DEVICE WAS USED FOR THE REPLACEMENT TO COMPLETE THE PROCEDURE. 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 17283178 ↗
• MalfunctionApr 3, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY (MRCA) THAT IS 80% STENOSED. THE 2.5X30MM TREK BALLOON DILATATION CATHETER WAS INFLATED; HOWEVER, THE IT WAS NOTED THE LOCATION OF TWO MARKERS OF THE BALLOON WERE NOT AT THE SHOULDER OF THE BALLOON. THE MARKERS WERE LOCATED MORE DISTAL THAN NORMAL; THEREFORE, THE PROXIMAL NOSE CONE LOOKED LONGER THAN USUAL. THE DEVICE WAS CONTINUED TO BE USED TO FINISH THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16666237 ↗
• MalfunctionAug 19, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ANTERIOR INTERVENTRICULAR ARTERY. A 2.5X30MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND DILATED THE TARGET LESION WITHOUT ISSUE. THE BDC WAS LEFT IN THE ANATOMY WHEN A NON-ABBOTT STENT WAS THEN INSERTED AND PLACED THE STENT BELOW THE BDC. ONCE THE NON-ABBOTT STENT REACHED THE TARGET LESION, THE STENT FAILED TO DEPLOY AS IT BECAME STUCK WITH THE BDC. THE STENT IMPLANT WAS NOTED AS FLARED AND WAS DECIDED TO SIMPLY WITHDRAW THE STENT DEVICE. ANOTHER STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE TREK BALLOON REMAINED IN THE ANATOMY WHILE THE FIRST NON-ABBOT STENT WAS REMOVED AND WAS USED WITH THE SECOND SUCCESSFUL STENT WITHOUT ISSUE. 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 15261043 ↗
• MalfunctionAug 15, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTALLY OCCLUDED, PROXIMAL CIRCUMFLEX CORONARY ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 2.5X30 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE WITH THE ANATOMY NOTED. THE BALLOON WAS INFLATED 5 TIMES AND RUPTURED AT 10 ATMOSPHERES (ATM) FOR 5 SECONDS. A 2.5X20 MM TREK BDC WAS USED TO COMPLETE THE PROCEDURE. 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 15229425 ↗
• MalfunctionAug 8, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS LESION IN THE LEFT CIRCUMFLEX (CX) ARTERY. A 2.5X30MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE MET FROM THE ANATOMY AND WAS UNABLE TO REACH THE TARGET LESION. THE BDC WAS REMOVED WITH RESISTANCE FROM THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188675 ↗
• MalfunctionMay 7, 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 LEFT ANTERIOR DESCENDING ARTERY. THE 2.5X30MM TREK BALLOON DILATATION CATHETER RUPTURED AT 18 ATMOSPHERES DURING THE SECOND INFLATION. IT WAS NOTED THAT THE DEVICE WAS NOT SOAKED PRIOR TO USE. A 2.5X38MM XIENCE SKYPOINT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14317058 ↗
• MalfunctionApr 1, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) WITH HEAVY CALCIFICATION. A 2.50 X 30MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR DILATATION; HOWEVER, RESISTANCE WAS MET WITH THE ANATOMY. THEN DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES. THE BDC WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED. THE PROCEDURE CONTINUED AND THE TARGET LESION WAS SUCCESSFULLY TREATED WITH A 2.5X33MM STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13972924 ↗
• MalfunctionApr 2, 2021Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE HEAVILY CALCIFIED CIRCUMFLEX (CX) ARTERY. A NON-ABBOTT ROTATIONAL ATHETECTOMY DEVICE WAS USED, THEN THE 2.5 X 30 MM TREK DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION. THE TREK DILATATION CATHETER BALLOON WAS INFLATED TO 13 ATMOSPHERES (ATM), THEN WOULD NOT INFLATE ANY MORE. THERE WAS NO LEAK NOTED AND NO BALLOON RUPTURE WAS SUSPECTED, AS THERE WAS NO BLEED BACK NOTED. THE BALLOON SEEMED TO BE FULLY INFLATED AND THE BALLOON DEFLATED WITHOUT ISSUE. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND THERE WAS NO ADVERSE PATIENT EFFECT. ADDITIONAL ROTATIONAL ATHERECTOMY WAS PERFORMED, AND AN NC TREK WAS THEN USED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. RETURNED DEVICE ANALYSIS INDICATES THAT A LEAK WAS OBSERVED IN THE DILATATION CATHETER BALLOON. ADDITIONAL FOLLOW UP WITH THE SITE INDICATED THAT NO LEAK WAS NOTED BY THE PHYSICIAN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11611462 ↗
• MalfunctionMar 10, 2020Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.50X30MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH NO ISSUES. THE BALLOON WAS INFLATED THREE TIMES TO 12, 14, AND 18 ATMOSPHERES (ATM) RESPECTIVELY. DURING REMOVAL, LIGHT RESISTANCE WAS MET WITH THE GUIDE CATHETER. ONCE THE BDC WAS REMOVED, IT WAS NOTED THE BALLOON WAS NO LONGER ATTACHED, IT WAS NOTED AT THE TIP OF THE GUIDE CATHETER UNDER FLUORO. THE GUIDE CATHETER AND GUIDE WIRES WERE REMOVED AS A SYSTEM WITH THE SEPARATED PORTION OF THE BALLOON. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9812137 ↗
• InjuryFeb 13, 2020Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  N/A

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9707723 ↗
• InjuryJan 28, 2020Deflation 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 DURING A LEFT MAIN/LEFT ANTERIOR DESCENDING CORONARY ARTERY INTERVENTION, DURING USE OF A TREK BALLOON DILATATION CATHETER, THE BALLOON FAILED TO DEFLATE, AND THE SHAFT SEPARATED. THE SEPARATED PORTION WAS SUCCESSFULLY SNARED OUT OF THE ANATOMY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9639954 ↗
• MalfunctionJul 9, 2019Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. DURING PREPARATION, THE AIR WAS ASPIRATED FROM A 2.50 X 30 MM TREK RX BALLOON DILATATION CATHETER (BDC); HOWEVER, THE BALLOON WAS NOT SOAKED. THE BDC WAS ADVANCED TO THE LESION FOR PRE-DILATATION WITH NO RESISTANCE; HOWEVER, THE BALLOON RUPTURED ON THE FIRST INFLATION AT 10 ATMOSPHERES. A 3.0 X 15 MM NC TREK BDC WAS USED TO COMPLETE PRE-DILATATION PRIOR TO A 3.0 X 48 MM XIENCE STENT BEING DEPLOYED. POST-DILATION WAS PERFORMED WITH A 3.75 X 8 MM NON-ABBOTT BDC 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 Consequences Or Impact To Patient

  MAUDE report 8773777 ↗
• MalfunctionFeb 26, 2019Off-Label Use; Difficult to Remove; Material Separation; Off-Label Use; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT LEG, BELOW THE KNEE. THE 2.50X30MM RX TREK WAS USED TO OCCLUDE THE ACCESS SITE IN THE RIGHT FOOT. DURING REMOVAL OF THE DEVICE, THE RX TREK BECAME STUCK ON THE IRONMAN GUIDE WIRE THEREFORE THE DEVICES WERE REMOVED TOGETHER. OUTSIDE THE ANATOMY, DURING REMOVAL OF THE RX TREK, THE DISTAL SHAFT SEPARATED AND REMAINED ON THE GUIDE WIRE. 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 8371646 ↗