HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009665Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08717648118722), received between Jan 5, 2018 and Aug 28, 2024 — classified as 6 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2024Material Separation; Material Too Soft/Flexible; Material Separation; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATE TO HEAVY CALCIFIED ANTERIOR TIBIAL ARTERY. THE HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE WAS PLACED IN THE VESSEL AND AN UNSPECIFIED BALLOON WAS USED FOR SUPPORT. DURING REMOVAL OF THE BALLOON THE GUIDE WIRE SEPARATED 30-40CM FROM THE DISTAL TIP AND THE SEPARATED PORTION WAS SEEN IN THE PATIENT. THE DETACHED SEPARATED PORTION WAS REMOVED VIA SNARE. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20087040 ↗
• MalfunctionApr 15, 2024Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE BMW UNIVERSAL II GUIDE WIRE WAS ADVANCED INTO THE PATIENT WITHOUT ISSUE. THE 2.0X15MM RX MINI TREK BALLOON DILATATION CATHETER WAS ADVANCED OVER THE GUIDE WIRE HOWEVER LIGHT RESISTANCE WAS FELT AND IT WAS NOTED THE GUIDE WIRE TIP HAD SEPARATED INSIDE THE CATHETER LUMEN. THE DEVICES WERE REMOVED TOGETHER WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER SAME SIZE MINI TREK AND BMW UNIVERSAL II GUIDE WIRE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105282 ↗
• InjuryMar 26, 2024Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT THE HT BMW UNIVERSAL II 300CM GUIDEWIRE (GW) WAS ATTEMPTED TO BE USED IN A PROCEDURE; HOWEVER, THE TIP OF THE GW WAS CATCHING DURING ADVANCEMENT ON THE INTRODUCER NEEDLE WHILE THE GW WAS STILL IN THE GUIDE CATHETER. THEREFORE, THE GW WAS REMOVED FROM THE PATIENT AND THE TEFLON COATING OF THE GW WAS NOTED TO BE MISSING AND A TRANSITION BUMP WAS FELT. IT IS UNKNOWN IF ANYTHING WAS LEFT IN THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18983812 ↗
• InjuryFeb 5, 2024Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT SUBCLAVIAN ARTERY WITH 95% STENOSIS. THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE HAD RESISTANCE DURING ADVANCEMENT AND FAILED TO CROSS WHEN IT BROKE INSIDE THE 6FRENCH (F) GUIDING CATHETER, HOWEVER, THE RESISTANCE WAS NOT WITH THE GUIDING CATHETER. THE BREAK WAS APPROXIMATELY 3-6 INCHES FROM THE TIP OF THE DEVICE. THE WIRE WAS SUCCESSFULLY RETRIEVED AND REMOVED FROM THE ANATOMY USING A SYRINGE AND NEGATIVE PRESSURE. NOTHING REMAINS IN THE PATIENT. ANOTHER NON-ABBOTT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELAE 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 18641419 ↗
• InjurySep 27, 2023Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUBCLAVIAN ARTERY WITH 85% STENOSIS, MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE HAD RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND FAILED TO CROSS THE LESION. THE TIP OF THE GUIDE WIRE SEPARATED INSIDE THE ANATOMY AND A SNARE DEVICE WAS USED TO RETRIEVE THE SEPARATED PORTION. THERE WAS NO RESISTANCE DURING REMOVAL. ANOTHER HT BMW UNIVERSAL II GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELAE 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 17824790 ↗
• MalfunctionJul 10, 2023Break; Break

  IT WAS REPORTED THAT THE PATIENT CAME TO THE HOSPITAL DUE TO CORONARY ATHEROSCLEROTIC HEART DISEASE. ON (B)(6) 2023, THE PATIENT UNDERWENT A PROCEDURE DUE TO OCCLUSION OF LEFT SUBCLAVIAN ARTERY. THE HT BMW UNIVERSAL II GUIDE WIRE WAS BEING USED TO DELIVER THE BALLOON AND STENT TO OPEN THE VESSEL FOR THE PATIENT. AFTER SUCCESSFULLY PRE-DILATING THE LESION, THE CONNECTION BETWEEN HYDROPHILIC COATING AND NON-HYDROPHILIC COATING OF GUIDE WIRE BROKE WHEN THE BALLOON WAS WITHDRAWN. THERE WAS CRACKING AT THE JUNCTION OF HYDROPHILIC AND HYDROPHOBIC COATINGS. IT WAS CONFIRMED THAT NO PART OF THE GUIDE WIRE REMAINED IN THE PATIENT'S ANATOMY. NEW PRODUCTS WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288806 ↗
• MalfunctionFeb 22, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE (GW) WAS REMOVED FROM THE ANATOMY TO BE RE-SHAPED, AND ONCE COMPLETELY REMOVED AND RE-SHAPING WAS BEING PERFORMED, THE TIP BROKE OFF. THERE WAS NO REPORTED RESISTANCE DURING ADVANCEMENT OR REMOVAL OF THE GW. ANOTHER BMW GW WAS USED 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 13581586 ↗
• InjuryOct 11, 2021Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY WITH MODERATE CALCIFICATION, 90% STENOSIS. THE BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE WAS ADVANCED BUT THE TIP BECAME CAUGHT BEHIND AN EXISTING STENT AND ABOUT 5 CM SEPARATED. THE TIP WAS NOT ABLE TO BE SNARED SO IT WAS CRUSHED TO THE VESSEL USING AN UNSPECIFIED 6.0.60X80 SELF EXPANDING STENT. THERE WERE NO ADVERSE PATIENT SEQUELA. SUBSEQUENT TO THE INITIALLY FILED REPORT THE FOLLOWING INFORMATION WAS PROVIDED: THE BMW GUIDE WIRE REACHED THE LESION BUT THERE WAS RESISTANCE WITH THE PREVIOUSLY IMPLANTED STENT. THERE WAS NO RESISTANCE DURING REMOVAL .

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12608792 ↗
• MalfunctionSep 20, 2021Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT CIRCUMFLEX CORONARY ARTERY. A 3X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS BEING USED WITH A BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE WHEN RESISTANCE WAS FELT BETWEEN THE DEVICES DURING ADVANCEMENT AND REMOVAL. THE INNER MEMBER OF THE BDC WAS NOTED TO BE SEPARATED, SO ALL DEVICES WERE REMOVED TOGETHER WITH THE SEPARATED PORTION. NO PORTION OF THE DEVICE REMAINS IN THE ANATOMY. AN UNSPECIFIED GUIDE WIRE AND BALLOON WERE USED 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 12499172 ↗
• MalfunctionMar 31, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. A BALANCE MIDDLEWEIGHT GUIDE WIRE WAS USED IN THE PROCEDURE WITHOUT ISSUE. AFTER THE GUIDE WIRE WAS REMOVED FROM THE ANATOMY AND WIPED DOWN, IT WAS ATTEMPTED TO BE PLACED BACK IN THE DISPENSER HOOP COIL, WHEN THE CORE BROKE IN TWO PIECES. THERE WAS NO RESISTANCE NOTED WHEN PLACING THE GUIDE WIRE BACK IN THE HOOP. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11595747 ↗
• InjuryFeb 16, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, NON-TORTUOUS RIGHT CORONARY ARTERY. AFTER REMOVAL OF THE HIGH-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDEWIRE WITHOUT ANY RESISTANCE NOTED, THE POLYMER COATING WAS NOTED TO BE SHAVED OFF. THE POLYMER SHAVINGS LEFT IN THE PATIENT WERE EMBEDDED TO THE VESSEL USING A BALLOON. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11334794 ↗
• MalfunctionApr 3, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING AN INCOMING CONSIGNMENT INSPECTION OF NINE HIGH-TORQUE BALANCE MIDDLE WEIGHT UNIVERSAL II GUIDE WIRES, THERE WAS WHAT APPEARED TO BE AIR BUBBLES INSIDE THE STERILE PACKAGING AROUND THE SEALS. WHILE THE SEALS APPEARED INTACT AND THERE WAS NO REPORTED PROBLEM WITH STERILITY OF THE GUIDE WIRES, THIS COULD NOT BE CONFIRMED. THE GUIDE WIRES WERE NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8478944 ↗
• MalfunctionApr 3, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING AN INCOMING CONSIGNMENT INSPECTION OF NINE HIGH-TORQUE BALANCE MIDDLE WEIGHT UNIVERSAL II GUIDE WIRES, THERE WAS WHAT APPEARED TO BE AIR BUBBLES INSIDE THE STERILE PACKAGING AROUND THE SEALS. WHILE THE SEALS APPEARED INTACT AND THERE WAS NO REPORTED PROBLEM WITH STERILITY OF THE GUIDE WIRES, THIS COULD NOT BE CONFIRMED. THE GUIDE WIRES WERE NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8478918 ↗
• MalfunctionApr 3, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING AN INCOMING CONSIGNMENT INSPECTION OF NINE HIGH-TORQUE BALANCE MIDDLE WEIGHT UNIVERSAL II GUIDE WIRES, THERE WAS WHAT APPEARED TO BE AIR BUBBLES INSIDE THE STERILE PACKAGING AROUND THE SEALS. WHILE THE SEALS APPEARED INTACT AND THERE WAS NO REPORTED PROBLEM WITH STERILITY OF THE GUIDE WIRES, THIS COULD NOT BE CONFIRMED. THE GUIDE WIRES WERE NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8478917 ↗
• MalfunctionApr 3, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING AN INCOMING CONSIGNMENT INSPECTION OF NINE HIGH-TORQUE BALANCE MIDDLE WEIGHT UNIVERSAL II GUIDE WIRES, THERE WAS WHAT APPEARED TO BE AIR BUBBLES INSIDE THE STERILE PACKAGING AROUND THE SEALS. WHILE THE SEALS APPEARED INTACT AND THERE WAS NO REPORTED PROBLEM WITH STERILITY OF THE GUIDE WIRES, THIS COULD NOT BE CONFIRMED. THE GUIDE WIRES WERE NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8478891 ↗
• MalfunctionApr 3, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING AN INCOMING CONSIGNMENT INSPECTION OF NINE HIGH-TORQUE BALANCE MIDDLE WEIGHT UNIVERSAL II GUIDE WIRES, THERE WAS WHAT APPEARED TO BE AIR BUBBLES INSIDE THE STERILE PACKAGING AROUND THE SEALS. WHILE THE SEALS APPEARED INTACT AND THERE WAS NO REPORTED PROBLEM WITH STERILITY OF THE GUIDE WIRES, THIS COULD NOT BE CONFIRMED. THE GUIDE WIRES WERE NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8478890 ↗
• MalfunctionApr 3, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING AN INCOMING CONSIGNMENT INSPECTION OF NINE HIGH-TORQUE BALANCE MIDDLE WEIGHT UNIVERSAL II GUIDE WIRES, THERE WAS WHAT APPEARED TO BE AIR BUBBLES INSIDE THE STERILE PACKAGING AROUND THE SEALS. WHILE THE SEALS APPEARED INTACT AND THERE WAS NO REPORTED PROBLEM WITH STERILITY OF THE GUIDE WIRES, THIS COULD NOT BE CONFIRMED. THE GUIDE WIRES WERE NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8478889 ↗
• MalfunctionApr 3, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING AN INCOMING CONSIGNMENT INSPECTION OF NINE HIGH-TORQUE BALANCE MIDDLE WEIGHT UNIVERSAL II GUIDE WIRES, THERE WAS WHAT APPEARED TO BE AIR BUBBLES INSIDE THE STERILE PACKAGING AROUND THE SEALS. WHILE THE SEALS APPEARED INTACT AND THERE WAS NO REPORTED PROBLEM WITH STERILITY OF THE GUIDE WIRES, THIS COULD NOT BE CONFIRMED. THE GUIDE WIRES WERE NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8478868 ↗
• MalfunctionApr 3, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING AN INCOMING CONSIGNMENT INSPECTION OF NINE HIGH-TORQUE BALANCE MIDDLE WEIGHT UNIVERSAL II GUIDE WIRES, THERE WAS WHAT APPEARED TO BE AIR BUBBLES INSIDE THE STERILE PACKAGING AROUND THE SEALS. WHILE THE SEALS APPEARED INTACT AND THERE WAS NO REPORTED PROBLEM WITH STERILITY OF THE GUIDE WIRES, THIS COULD NOT BE CONFIRMED. THE GUIDE WIRES WERE NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8478864 ↗
• MalfunctionApr 3, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING AN INCOMING CONSIGNMENT INSPECTION OF NINE HIGH-TORQUE BALANCE MIDDLE WEIGHT UNIVERSAL II GUIDE WIRES, THERE WAS WHAT APPEARED TO BE AIR BUBBLES INSIDE THE STERILE PACKAGING AROUND THE SEALS. WHILE THE SEALS APPEARED INTACT AND THERE WAS NO REPORTED PROBLEM WITH STERILITY OF THE GUIDE WIRES, THIS COULD NOT BE CONFIRMED. THE GUIDE WIRES WERE NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8478863 ↗
• MalfunctionJan 5, 2018Detachment Of Device Component; Difficult To Position; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO PERFORM A LEFT POPLITEAL BYPASS GRAFT. A 300 CM BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE WAS USED AND MET RESISTANCE WITH A NON-ABBOTT BALLOON CATHETER WHICH WAS INSIDE THE ANATOMY DURING ADVANCEMENT. ADDITIONALLY, THE CORE OF THE GUIDE WIRE SEPARATED INSIDE THE BALLOON CATHETER. THE SEPARATION OCCURRED OUTSIDE THE ANATOMY; THEREFORE, BOTH DEVICES WERE SIMPLY WITHDRAWN FROM THE ANATOMY. THEN, THE DEVICES WERE REPLACED WITH A 3.0 X 20 MM AND A 3.5 X 15 MM NON-ABBOTT BALLOON CATHETER 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 7168350 ↗