HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL 1009660JRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08717648065866), received between Oct 26, 2016 and Nov 25, 2025 — classified as 6 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (15 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT IN-STENT THROMBOSIS OF A STENT IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING REMOVAL OF THE BMW UNIVERSAL GUIDE WIRE, IT CAUGHT ON THE PREVIOUSLY IMPLANTED STENT AND THE TIP SEPARATED. THE DISTAL END WAS ANCHORED TO THE DIAGONAL, AND THE PROXIMAL END ANCHORED WITH THE STENT FROM THE PREVIOUS PROCEDURE IN THE COMMON TRUNK, WITH THE PROXIMAL SEGMENT FREE FLOATING IN AORTA. THE PATIENT REMAINED HOSPITALIZED FOR OBSERVATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23643614 ↗
• MalfunctionNov 10, 2025Break; Break

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE DIAGONAL BRANCH. AT THE END OF THE PROCEDURE, THE BMW UNIVERSAL GUIDE WIRE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THE GUIDE WIRE HAD DELAMINATED. 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 23511054 ↗
• MalfunctionAug 27, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN A DE NOVO LESION IN THE ANTERIOR DESCENDING ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) GUIDEWIRE GOT CAUGHT INSIDE THE DRAGONFLY OPSTAR IMAGING CATHETER AND TIP OF THE CATHETER WAS NOTED TO HAVE A HOLE AFTER REMOVAL AS A SINGLE UNIT. ANOTHER HT BMW AND DRAGONFLY OPSTAR WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 22906573 ↗
• MalfunctionAug 25, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MODERATELY CALCIFIED, MODERATELY TORTUOUS POSTERIOR DESCENDING ARTERY. THE BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL GUIDE WIRE WAS NOTED TO HAVE RESISTANCE WHEN ADVANCED OUT OF THE GUIDING CATHETER. A DRAGONFLY IMAGING CATHETER WAS USED IN THE PROCEDURE AND IT WAS NOTED WHEN PULLBACK WAS COMPLETE THAT THE GUIDE WIRE AND THE DRAGONFLY WERE STUCK TOGETHER AND THE DEVICES WERE REMOVED TOGETHER AS A SINGLE UNIT. ANOTHER SAME SIZE BMW GUIDE WIRE 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 22885218 ↗
• MalfunctionAug 11, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE CORE OF THE GUIDE WIRE WAS SEPARATED. THE SEPARATION OCCURRED DURING SIMPLE WITHDRAWAL FROM THE ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22773456 ↗
• MalfunctionMay 22, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THE PROCEDURE THE DRAGONFLY OPSTAR IMAGING CATHETER WAS USED IN THE DE NOVO ANTERIOR DESCENDING ARTERY WITH MODERATE TORTUOSITY. AFTER THE FOURTH AND LAST PULLBACK, AN ISSUE WITH THE IMAGING CATHETER WAS ENCOUNTERED. THE IMAGING CATHETER COULD NOT BE EXTRACTED DUE TO ENTANGLEMENT WITH THE GUIDEWIRE (BALANCE MIDDLEWEIGHT 0.014). AS A RESULT, BOTH DEVICES HAD TO BE RETRIEVED TOGETHER AS ONE UNIT. 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 22073104 ↗
• MalfunctionApr 17, 2025Product Quality Problem; Difficult to Remove; Difficult to Advance; Product Quality Problem; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE DESCENDENT POSTERIOR ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE HT BMW UNIVERSAL 190 CM GUIDE WIRE (GW) WAS USED IN THE PROCEDURE; HOWEVER, THE GW FELT AS IF THE GW WAS LOSING HYDROPHILICITY DURING USE RESULTING IN RESISTANCE WITH UNSPECIFIED BALLOONS AND UNSPECIFIED STENTS IN THE PROCEDURE CAUSING THE GW TO BECOME STUCK. 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 21862190 ↗
• MalfunctionFeb 20, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN A 70% STENOSED LESION THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH MODERATE CALCIFICATION. THE FIRST HT-BMW UNIVERSAL 190CM J GUIDE WIRE (GW) WAS USED IN THE PROCEDURE; HOWEVER, AN UNSPECIFIED STENT AND AN UNSPECIFIED BALLOON COULD NOT BE REMOVED FROM THE GW. THEREFORE, ANOTHER HT-BMW UNIVERSAL GW WAS USED TO CONTINUE THE PROCEDURE; HOWEVER, AN UNSPECIFIED STENT AND AN UNSPECIFIED BALLOON ALSO COULD NOT BE REMOVED FROM THE GW. A THIRD GW WAS USED TO COMPLETE 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 21423304 ↗
• MalfunctionFeb 20, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN A 70% STENOSED LESION THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH MODERATE CALCIFICATION. THE FIRST HT-BMW UNIVERSAL 190CM J GUIDE WIRE (GW) WAS USED IN THE PROCEDURE; HOWEVER, AN UNSPECIFIED STENT AND AN UNSPECIFIED BALLOON COULD NOT BE REMOVED FROM THE GW. THEREFORE, ANOTHER HT-BMW UNIVERSAL GW WAS USED TO CO ERE 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 21423212 ↗
• MalfunctionNov 14, 2024Scratched Material; Insufficient Device Problem Information; Scratched Material; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE TEFLON COATING WAS SCRAPED SPORADICALLY THROUGHOUT THE LENGTH OF THE CORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684912 ↗
• MalfunctionJul 12, 2024Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WAS REMOVED FROM THE DISPENSER COIL AND NOTED TO BE BENT AT THE JUNCTION BETWEEN THE TIP AND CORE. WHEN THE GUIDE WIRE WAS ATTEMPTED TO BE BENT BACK, IT SEPARATED BETWEEN THE TIP AND CORE. ANOTHER BALANCE MIDDLEWEIGHT GUIDE WIRE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730958 ↗
• InjuryMar 7, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  SUBSEQUENT TO THE INITIALLY FILED REPORTS, ADDITIONAL INFORMATION WAS PROVIDED. IT WAS REPORTED THE PROCEDURE WAS TO TREAT A TORTUOUS LESION IN THE RIGHT RADIAL ARTERY. DURING REMOVAL OF THE BMW UNIVERSAL GUIDE WIRE, RESISTANCE WAS MET WITH THE ANATOMY DUE TO A SEVERE SPASM AND THE GUIDE WIRE SEPARATED. THE SEPARATED PORTION OF THE GUIDE WIRE WAS SURGICALLY REMOVED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18855096 ↗
• MalfunctionJun 14, 2023Difficult to Remove; Material Separation; Failure to Advance; Difficult to Remove; Material Separation; Failure to Advance

  RETURNED DEVICE ANALYSIS DO NOT IDENTIFIED A SEPARATION IN THE DISTAL TIP; HOWEVER, THE ACCOUNT STATED THAT THERE WAS NO GUIDE WIRE SEPARATION DURING PROCEDURE AND THIS WAS ONLY A REPORT OF RESISTANCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17128205 ↗
• MalfunctionMar 16, 2023Material Separation; Stretched; Material Separation; Stretched

  SUBSEQUENT TO THE INITIALLY FILED REPORTS, RETURNED DEVICE ANALYSIS IDENTIFIED THAT THERE WAS NO BREAK OR SEPARATION ON EITHER WIRE AS REPORTED. THE ACCOUNT STATED THAT STRETCHED COILS ARE WHAT THE ACCOUNT REPORTED AS BROKEN AND SEPARATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16553970 ↗
• MalfunctionMar 16, 2023Break; Stretched; Break; Stretched

  SUBSEQUENT TO THE INITIALLY FILED REPORTS, RETURNED DEVICE ANALYSIS IDENTIFIED THAT THERE WAS NO BREAK OR SEPARATION ON EITHER WIRE AS REPORTED. THE ACCOUNT STATED THAT STRETCHED COILS ARE WHAT THE ACCOUNT REPORTED AS BROKEN AND SEPARATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16553969 ↗
• InjuryOct 21, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL GUIDE WIRE DISTAL TIP (9.5CM) SEPARATED IN THE ANATOMY. THERE WAS NO RESISTANCE DURING ADVANCEMENT AND REMOVAL. AFTER EXTENSIVE WORK THE DISTAL TIP WAS RETRIEVED WITH A SNARE DEVICE. NOTHING ANGIOGRAPHICALLY DETECTABLE, NO EVIDENCE OF ECHOCARDIOGRAM (ECG) CHANGES OR CHANGES OF SYMPTOMS CONFIRM NOTHING WAS LEFT IN THE PATIENT. A DISSECTION OCCURRED DURING SNARING AND RETRIEVAL OF THE DISTAL END OF THE GUIDE WIRE. THERE WAS NO ADVERSE PATIENT SEQUELA; HOWEVER, THERE WAS A CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 15651344 ↗
• MalfunctionMar 24, 2022Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH NO TORTUOSITY. A BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL GUIDE WIRE FRACTURED DURING ADVANCEMENT INTO THE GUIDING CATHETER. THERE WAS NO RESISTANCE DURING ADVANCEMENT. A NEW BMW UNIVERSAL GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13895736 ↗
• MalfunctionNov 12, 2021Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MODERATELY TORTUOUS VESSEL IN THE RIGHT CORONARY ARTERY (RCA). THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL GUIDE WIRE WAS ATTEMPTED TO BE ADVANCED WITHOUT RESISTANCE, HOWEVER, IT WAS FOUND BY FLUOROSCOPY THAT THE GUIDE WIRE TIP WAS FRACTURED. THE HT BMW WAS WITHDRAWN AND ANOTHER BMW WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO RESISTANCE DURING WITHDRAWAL. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12807778 ↗
• MalfunctionApr 9, 2021Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL GUIDE WIRE WAS REMOVED FROM THE DISPENSER HOOP AND PREPARED. THE GUIDE WIRE WAS ADVANCED WITHOUT RESISTANCE, BUT AS IT EXITED THE GUIDE CATHETER, IT WAS NOTED ON FLUOROSCOPY THAT THE GUIDE WIRE WAS FRACTURED AT THE TIP. THE GUIDE WIRE WAS REMOVED AND ANOTHER BMW GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 11641961 ↗
• MalfunctionJan 26, 2021Break; Break

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION IN THE ANTERIOR DESCENDING ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. A 190 CM HT BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE (GW) WAS ADVANCED TO THE TARGET LESION. HOWEVER, WHEN THE GW WAS REMOVED FROM THE PATIENT, THE GW TIP WAS OBSERVED TO BE BROKEN. THE TIP COILS WERE SEPARATED BUT HELD TOGETHER BY THE CORE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW GW. 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 11230933 ↗
• MalfunctionJan 14, 2021Break; Break

  IT WAS REPORTED THAT BEFORE USE, AFTER REMOVING THE BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL GUIDE WIRE FROM THE DISPENSER HOOP, THE TIP WAS NOTED TO BE FRACTURED. THERE WAS NO DAMAGE NOTED TO THE DISPENSER HOOP OR CHIPBOARD BOX. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER BMW UNIVERSAL GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 11174681 ↗
• InjuryDec 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNSPECIFIED CORONARY ARTERY. A UNIVERSAL BALANCE MIDDLEWEIGHT GUIDE WIRE BECAME SEPARATED IN THE ANATOMY, AND THE SEPARATED PORTION WAS EMBEDDED WITH AN UNSPECIFIED STENT. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 10977568 ↗
• MalfunctionSep 18, 2020Material Separation; Material Separation

  IT WAS REPORTED DURING REMOVAL OF A HT BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE FROM THE DISPENSER HOOP COIL THE TIP WAS NOTED TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10555411 ↗
• MalfunctionJul 30, 2020Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  SUBSEQUENT TO THE INITIAL FILED REPORT ADDITIONAL INFORMATION WAS RECEIVED: THE BMW UNIVERSAL GUIDE WIRE WAS ADVANCED THROUGH A 6FR GUIDE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10345268 ↗
• MalfunctionNov 25, 2019Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE KINKED AND THEN SEPARATED AT THE TRANSITION OF THE HYPOTUBE PRIOR TO ENTERING AN UNSPECIFIED GUIDE WIRE INTRODUCER. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NON-ABBOTT GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 140 UNUSED/STERILE GUIDE WIRES FROM TWO DIFFERENT LOT NUMBERS WILL BE RETURNING, AND TWO DEVICES FOR EACH LOT NUMBER WERE OPENED AND MANIPULATED BY THE PHYSICIAN, WHICH RESULTED IN THE SAME KINK AND SEPARATION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9370724 ↗