HI-TORQUE BALANCE MIDDLEWEIGHTRecalls & reported problems across all models

We found 13 models of HI-TORQUE BALANCE MIDDLEWEIGHT by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 354 adverse event reports in the FDA's MAUDE database, received between Aug 29, 2016 and Sep 24, 2026 — classified as 2 deaths, 145 injuries, 207 malfunctions.

The most frequently reported specific device problem is “Material Separation” (158 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 problems

HI-TORQUE BALANCE MIDDLEWEIGHT models

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

• HI-TORQUE BALANCE MIDDLEWEIGHT 1001780-HC

  WIRE, GUIDE, CATHETER
  1 death156 reports
• HI-TORQUE BALANCE MIDDLEWEIGHT 1001780J-HC

  WIRE, GUIDE, CATHETER
  80 reports
• HI-TORQUE BALANCE MIDDLEWEIGHT™ 1011880

  WIRE, GUIDE, CATHETER
  1 death26 reports
• HI-TORQUE BALANCE MIDDLEWEIGHT 1001780J

  WIRE, GUIDE, CATHETER
  25 reports
• HI-TORQUE BALANCE MIDDLEWEIGHT 1001780

  WIRE, GUIDE, CATHETER
  23 reports
• HI-TORQUE BALANCE MIDDLEWEIGHT 1001782-HC

  WIRE, GUIDE, CATHETER
  13 reports
• HI-TORQUE BALANCE MIDDLEWEIGHT™ 1011880J

  WIRE, GUIDE, CATHETER
  13 reports
• HI-TORQUE BALANCE MIDDLEWEIGHT 1001782J-HC

  WIRE, GUIDE, CATHETER
  9 reports
• HI-TORQUE BALANCE MIDDLEWEIGHT 1001782

  WIRE, GUIDE, CATHETER
  5 reports
• HI-TORQUE BALANCE MIDDLEWEIGHT 1001782J

  WIRE, GUIDE, CATHETER
  1 report
• HI-TORQUE BALANCE MIDDLEWEIGHT™ 1011881

  WIRE, GUIDE, CATHETER
  1 report
• HI-TORQUE BALANCE MIDDLEWEIGHT™ 1011882

  WIRE, GUIDE, CATHETER
  1 report
• HI-TORQUE BALANCE MIDDLEWEIGHT™ 1011883

  WIRE, GUIDE, CATHETER
  1 report

Recent HI-TORQUE BALANCE MIDDLEWEIGHT adverse event reports

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

• InjurySep 24, 2026Break; Entrapment of Device

  It was reported that the procedure was to treat a heavily calcified, heavily tortuous right coronary artery lesion with 99% stenosis. A Hi-Torque 014 Balance Middleweight (BMW) guide wire was advanced for use. During removal through the guide catheter, resistance was noted and the guide wire core broke, but remained in one piece. A snare was used to retrieve the guide wire. A new BMW guide wire was used to continue 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 50886310 ↗
• MalfunctionSep 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857738 ↗
• MalfunctionSep 21, 2026Material Separation

  It was reported the procedure was to treat a lesion in the Right Coronary Artery. The Hi-Torque BMW guide wire was advanced into the patient however the radiopaque tip was not visible on fluoro as it had separated. As a result, the procedure could not be completed due to the absence of the radiopaque feature. There were no adverse patient effects. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841068 ↗
• InjurySep 18, 2026Material Separation

  It was reported that the procedure was to treat a heavily calcified, mildly tortuous 1st diagonal artery lesion with chronic total occlusion. A 014 Hi-Torque BMW guide wire was prepared advanced without issue. Two non-Abbott stents were implanted without issue. However, during removal, the guide wire tip separated. A snare was used to retrieve the wire tip, but the tip was lost in the aorta. A vascular retriever was then used to successfully retrieve the wire tip and 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 50821545 ↗
• InjurySep 15, 2026Difficult to Remove; Material Separation; Stretched

  It was reported the procedure was to treat a lesion in the Right Coronary Artery (RCA). The BMW Hydro guide wire was used in the procedure. After successfully stenting the lesions, the guide wire was retracted with some resistance. Outside of the anatomy it was noted the guide wire was frayed and the distal tip was missing. Fluoro images confirmed a small portion of the distal tip of the guide wire was wedged under the stent struts. No additional information was provided.

  Patient problems: Foreign Body In Patient

  MAUDE report 50772039 ↗
• MalfunctionSep 2, 2026Difficult to Remove; Improper or Incorrect Procedure or Method

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572288 ↗
• MalfunctionAug 3, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50123715 ↗
• MalfunctionAug 3, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50123714 ↗
• InjuryJun 10, 2026Entrapment of Device; Difficult to Remove; Material Separation

  SUBSEQUENT TO THE INITIAL REPORT BEING FILED, IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SIDE BRANCH OF THE LEFT MAIN CORONARY ARTERY. THE SEPARATION WAS AT THE CORE OF THE GUIDE WIRE (GW) WHICH OCCURRED DUE TO THE GW BECAME JAILED WITH THE UNSPECIFIED STENT THAT WAS IMPLANTED IN THE PROCEDURE.NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25462732 ↗
• MalfunctionMar 2, 2026Break; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, MODERATELY TORTUOUS FIRST OBTUSE MARGINAL LESION. A HI-TORQUE 014 BMW HYDRO GUIDE WIRE WAS USED; HOWEVER, THE GUIDE WIRE COILS UNRAVELED INSIDE THE CORONARY ARTERY, BUT THE CORE REMAINED INTACT. AN ADDITIONAL BMW GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA 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 24490068 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT PRIOR TO USE, THE TIP OF THE BALANCE MIDDLEWEIGHT HYDRO GUIDE WIRE WAS NOTED TO BE BROKEN. THERE WAS NO REPORTED DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER BMW GUIDE WIRE WAS USED TO COMPETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24239988 ↗
• MalfunctionDec 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. AFTER THE BALANCE MIDDLEWEIGHT (BMW) HYDRO GUIDE WIRE WAS REMOVED FROM THE DISPENSER HOOP, IT WAS NOTED THAT THE WIRE WAS SEPARATED IN 2 PIECES. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907500 ↗
• InjuryDec 18, 2025Difficult to Remove; Material Separation; Stretched; Difficult to Remove; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE FIRST OBTUSE MARGINAL (OM1) AND LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERIES WITH 85-95% STENOSIS AND CALCIFICATION. LEFT RADIAL ACCESS WAS GAINED AND A 6FR 4.5 GUIDE CATHETER WAS ADVANCED AND SEATED COAXIALLY IN THE OSTIUM OF THE LEFT MAIN (LM). THE BLANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS INSERTED AND ADVANCED WITHOUT DIFFICULTY TO THE DISTAL OM1. A 2.5X15 MM TREK BALLOON WAS USED FOR PRE-DILATATION AND THE DRAGONFLY OPSTAR IMAGING CATHETER WAS ADVANCED. ONE RUN WAS SUCCESSFULLY IMAGED. UPON REMOVAL OF THE DRAGONFLY, THERE WAS A LOT OF RESISTANCE. THE GUIDE WIRE AND DRAGONFLY HAD TO BE REMOVED TOGETHER AS A UNIT. ONCE OUTSIDE THE ANATOMY, THE WIRE WAS FOUND TO BE FRAYED AND COILED LIKE A RIBBON. THE ANATOMY WAS IMAGED AGAIN WITH FLUORO AND A PIECE OF WIRE WAS SEEN IN THE VESSEL. A SNARE WAS UNSUCCESSFUL. A 2.75X28 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO EMBED THE WIRE PIECE INTO THE VESSEL WALL; HOWEVER, IT COULD NOT CROSS. A 2.5 MM TREK BALLOON WAS ULTIMATELY USED TO TACK THE WIRE PIECE TO THE VESSEL WALL AND A NON-ABBOTT STENT WAS IMPLANTED. A FINAL OCT RUN WAS PERFORMED WITH A NEW DR

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23844706 ↗
• InjuryNov 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE BMW HYDRO GUIDE WIRE WAS USED DURING THE PROCEDURE HOWEVER AFTER THE GUIDE WIRE WAS REMOVED, IT WAS NOTED THE TIP OF THE GUIDE WIRE UNRAVELED AND BROKE OFF INSIDE THE PATIENT. A STENT WAS DEPLOYED OVER THE SEPARATED PORTION EMBEDDING IT INTO THE VESSEL. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23660504 ↗
• MalfunctionNov 7, 2025Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE DISTAL THIRD OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) GUIDEWIRE WAS ADVANCED AND THE DRAGONFLY OPSTAR IMAGING CATHETER WAS USED FOR IMAGING WITHOUT ISSUE. A STENT WAS IMPLANTED AND THE IMAGING CATHETER WAS ADVANCED FOR POST-RUN EXECUTION WHEN AN ERROR MESSAGE "CONNECTION FAILURE 395 - THE IMAGING CATHETER COULD NOT BE CONNECTED. PLEASE UNLOAD AND TRY AGAIN (CAL-002)". THE HT BMW GUIDEWIRE WAS BEING REMOVED WHEN RESISTANCE WITH THE CATHETER WAS NOTED SINCE SLIDING WAS NOT EASY BUT REMOVED INDEPENDENTLY. A MINOR DAMAGE [BENT TIP] WAS NOTED ON THE RADIOPAQUE TIP OF THE GUIDEWIRE. ALSO UPON INSPECTION OF THE DRAGONFLLY OPSTAR, A LIGHT SIGNAL AT THE SECOND MARKER OF THE LENS WAS OBSERVED AND POSSIBLE DAMAGED LENS. THE PROCEDURE WAS COMPLETED AT THIS POINT WITHOUT THE FINAL POST-PROCEDURE IMAGING. 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 23500962 ↗

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