HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSALRecalls & reported problems across all models

We found 4 models of HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 141 adverse event reports in the FDA's MAUDE database, received between Aug 10, 2016 and Jul 20, 2026 — classified as 48 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (72 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL problems

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL 1009660

  WIRE, GUIDE, CATHETER
  93 reports
• HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL 1009660J

  WIRE, GUIDE, CATHETER
  32 reports
• HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL 1009661

  WIRE, GUIDE, CATHETER
  14 reports
• HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL 1009661J

  WIRE, GUIDE, CATHETER
  2 reports

Recent HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25873527 ↗
• MalfunctionJan 23, 2026Difficult to Remove; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY. THE BMW UNIVERSAL WAS USED DURING THE PROCEDURE ALONG WITH A RUN THROUGH GUIDE WIRE HOWEVER DURING REMOVAL THE WIRES BECAME ENTANGLED AND THE TIP OF THE BMW UNIVERSAL BROKE OFF. 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 24160321 ↗
• MalfunctionDec 29, 2025Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL GUIDEWIRE CROSSED A STENT WAS IMPLANTED A COUPLE OF DAYS AGO; HOWEVER, THERE WAS RESISTANCE AT THE LOCATION OF THE STENT UPON RETRIEVAL OF THE GUIDEWIRE. THE BMW UNIVERSAL WAS REMOVED INDEPENDENTLY BUT THE TIP/COILS WERE STRETCHED/STRIPPED AND CORE BROKEN BUT HELD BY THE STRETCHED COILS. ANOTHER NON-ABBOTT GUIDEWIRE WAS 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 23908911 ↗
• MalfunctionDec 17, 2025Difficult to Remove; Stretched; Difficult to Remove; Stretched

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). DURING REMOVAL OF THE BMW UNIVERSAL GUIDE WIRE, RESISTANCE WAS MET WITH THE LESION. ONCE REMOVED FROM THE PATIENT, IT WAS NOTED THE TIP COILS WERE STRETCHED. ANOTHER GUIDE WIRE WAS USED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23827932 ↗
• InjuryDec 10, 2025Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE 190 CM BMW GUIDE WIRE TIP WAS SEPARATED AND NOT RETURNED. THE ACCOUNT STATED THAT THE WIRE SEPARATED AT THE BEGINNING OF THE CASE AFTER THE WIRE BECAME STUCK ON CALCIUM. THE SEPARATED PIECE COULD NOT BE LOCATED OR SEEN ON FLUORO. THE 300CM GUIDE WIRE TIP WAS ALSO SEPARATED AND NOT RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23773855 ↗
• MalfunctionDec 10, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE BALANCE MIDDLEWEIGHT GUIDEWIRE WAS USED WITH A NON-ABBOTT BALLOON AND HAD TO BE REMOVED TOGETHER AS ONE UNIT. AN UNSPECIFIED GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767169 ↗
• InjuryNov 25, 2025Material Separation; Material Separation

  MDR REPORT#: MW5177744. DURING A RIGHT HEART CATHETERIZATION, THE DISTAL PART OF THE BMW 300CM WIRE BROKE OFF INSIDE THE DISTAL RPA. WIRE FRAGMENT WAS RETAINED IN THE DISTAL RIGHT LOWER LOBAR LATERAL SEGMENTAL BRANCH. ADDITIONAL INFORMATION WAS RECEIVED. ATTEMPTS WERE MADE TO RETRIEVE THE SEPARATED PORTION OF THE GUIDE WIRE, HOWEVER WERE UNSUCCESSFUL. THE SEPARATED PORTION REMAINS IN THE DISTAL RIGHT LOWER LOBAR LATERAL SEGMENTAL BRANCH.

  Patient problems: Foreign Body In Patient

  MAUDE report 23643642 ↗
• 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 21, 2025Material Separation; Material Separation

  SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS REPORTED THE SEPARATED PIECE WAS REMOVED WHEN THE WIRE WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619381 ↗
• 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 ↗
• MalfunctionOct 28, 2025Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE MILDLY CALCIFIED AND TORTUOUS CIRCUMFLEX ARTERY. THE 2.50X15MM NC SCOREFLEX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER THE BMW UNIVERSAL GUIDE WIRE TO THE TARGET LESION. AFTER SUCCESSFUL DILATATION, AN ATTEMPT WAS MADE TO REMOVE THE SCOREFLEX FROM THE GUIDE WIRE HOWEVER IT REMAINED STUCK. THE DEVICES WERE REMOVED TOGETHER AND OUTSIDE THE ANATOMY IT WAS NOTED THE GUIDE WIRE WAS STRETCHED AND UNRAVELED HOWEVER REMAINED IN ONE PIECE. 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 23401964 ↗
• MalfunctionSep 23, 2025Break; Deformation Due to Compressive Stress; Difficult to Advance; Break; Deformation Due to Compressive Stress; Difficult to Advance

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE 190 CM BMW GUIDE WIRE TIP WAS SEPARATED AND NOT RETURNED. THE ACCOUNT STATED THAT THE WIRE SEPARATED AT THE BEGINNING OF THE CASE AFTER THE WIRE BECAME STUCK ON CALCIUM. THE SEPARATED PIECE COULD NOT BE LOCATED OR SEEN ON FLUORO. THE 300CM GUIDE WIRE TIP WAS ALSO SEPARATED AND NOT RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23124417 ↗
• MalfunctionAug 27, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESIONS IN THE LEFT ANTERIOR DESCENDING (LAD) AND LEFT MAIN (LM) ARTERIES. AFTER ROTABLATION, THE 3.5X20MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED ON A HI-TORQUE BMW UNIVERSAL 190CM GUIDE WIRE (GW). THE BDC WAS USED IN THE PROCEDURE; HOWEVER, WHEN ATTEMPTING TO DEFLATE THE BALLOON FOR 2-3 SECONDS, THE BALLOON WOULD NOT FULLY DEFLATE. AN ATTEMPT WAS MADE TO REMOVE THE BDC FROM THE GW; HOWEVER, THE DEVICE COULD NOT BE REMOVED FROM EACH OTHER AND RESISTANCE WAS NOTED BETWEEN THE DEVICES. AFTER, SEVERAL ATTEMPTS THE PHYSICIAN WAS ABLE TO REMOVED THE PARTIALLY DEFLATED BALLOON WITH THE GW AND 7 FR GUIDE CATHETER (GC) AS AS A SINGLE UNIT. THE PROCEDURE WAS CONTINUED WITH ANOTHER NC TREK NEO BDC. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910186 ↗
• 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 ↗

Other Abbott Vascular Inc. products

• MITRACLIP8 models · 5,973 reports · 2 recalls
• NC TREK56 models · 1,842 reports · 12 recalls
• Armada213 models · 1,904 reports
• Indeflator7 models · 1,196 reports · 9 recalls
• XIENCE Sierra56 models · 1,161 reports · 1 recall
• XIENCE Skypoint69 models · 1,142 reports
• Graftmaster15 models · 1,071 reports
• TREK50 models · 909 reports