HI-TORQUE BALANCE HEAVYWEIGHTRecalls & reported problems across all models

We found 4 models of HI-TORQUE BALANCE HEAVYWEIGHT by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Sep 16, 2016 and Oct 2, 2025 — classified as 15 injuries, 11 malfunctions.

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

HI-TORQUE BALANCE HEAVYWEIGHT models

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

• HI-TORQUE BALANCE HEAVYWEIGHT 1000462H

  WIRE, GUIDE, CATHETER
  13 reports
• HI-TORQUE BALANCE HEAVYWEIGHT 1000462HJ

  WIRE, GUIDE, CATHETER
  10 reports
• HI-TORQUE BALANCE HEAVYWEIGHT 1000463H

  WIRE, GUIDE, CATHETER
  2 reports
• HI-TORQUE BALANCE HEAVYWEIGHT 1000463HJ

  WIRE, GUIDE, CATHETER
  1 report

Recent HI-TORQUE BALANCE HEAVYWEIGHT adverse event reports

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

• InjuryOct 2, 2025Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT CIRCUMFLEX (RCX) ARTERY. A NON-ABBOTT MICROCATHETER DID NOT PASS THE LESION THEREFORE THE BHW GUIDE WIRE WAS ADVANCED AND ABLE TO CROSS THE DISTAL RCX. THE MICROCATHTER WAS ATTEMPTED TO BE ADVANCED OVER THE BHW WITH TURNING MOVEMENTS OF THE MICROCATHTER. DURING THIS TRY THE RADIOPAQUE TIP OF THE GUIDE WIRE BROKE INTO TWO PARTS. THE PROXIMAL END OF THE GUIDE WIRE WAS ABLE TO BE RETRACTED; HOWEVER THE TIP OF THE GUIDE WIRE WAS IN THE DISTAL PART OF THE RCX AND WAS NOT REMOVED. THE PATIENT REQUIRED AN EXTENDED HOSPITAL STAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23198549 ↗
• InjuryJun 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A PULMONARY VEIN. DURING THE PROCEDURE, THE 190CM HI-TORQUE (HT) 014 BALANCE HEAVYWEIGHT (BHW) HYDRO GUIDE WIRE SEPARATED APPROXIMATELY 30CM FROM THE DISTAL TIP AND WAS RETRIEVED USING A SNARE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22232782 ↗
• InjuryJun 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THE BHW HYDRO GUIDE WIRE (GW) WAS PLACED IN A SAPHENOUS VEIN. THE PROCEDURE CONTINUED TO ADDRESS OTHER LESIONS; HOWEVER UPON COMPLETION, WHEN ATTEMPTING TO REMOVE THE BHW, IT WAS NOTICED THAT PART OF THE GW WAS OUTSIDE THE CATHETER WHILE ANOTHER PART PROTRUDED THROUGH THE CATHETER INTO THE SAPHENOUS VEIN. THE GUIDEWIRE HAD SEPARATED INTO TWO PIECES. SINCE THE DISTAL PART REMAINED INSIDE THE CATHETER FOR ABOUT 5 CM, IT WAS CAPTURED WITH A BALLOON AND THE ENTIRE ASSEMBLY (CATHETER, PART OF THE GUIDEWIRE, AND BALLOON) WAS REMOVED. 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 22227095 ↗
• MalfunctionJun 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THE BHW HYDRO GUIDE WIRE (GW) WAS SET ASIDE TO SOAK PRIOR TO USE. WHEN IT WAS PICKED UP AGAIN IT WAS NOTED THE GUIDE WIRE WAS SEPARATED APPROXIMATELY 39CM FROM THE DISTAL TIP. 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 22151277 ↗
• MalfunctionMay 29, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNKNOWN VESSEL. A 190CM HI-TORQUE 014 BHW HEAVYWEIGHT GUIDEWIRE (GW) WAS INSERTED INTO THE ANATOMY; HOWEVER, A FLAW ON THE RADIO MARKER WAS NOTED [POTENTIAL VISIBILITY ISSUES]. THEREFORE, THE DEVICE COULD NOT BE USED. THE PROCEDURE WAS CONTINUED WITH THE USE OF A NON-ABBOTT DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106252 ↗
• InjuryJan 7, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO IMPLANT A NON-ABBOTT PACEMAKER IN AN UNKNOWN CORONARY ARTERY. A 190CM HI-TORQUE BMW GUIDEWIRE (GW) WAS ADVANCED INTO THE ANATOMY; HOWEVER, A DISSECTION WAS NOTED IN THE BRACHIAL ARTERY, AND THE TIP OF GW WAS NOTED TO BE SEPARATED IN THE FLAP OF THE DISSECTION. THE SEPARATED TIP WAS ATTEMPTED TO BE RETRIEVED USING A SNARE DEVICE BUT WAS UNABLE TO BE RETRIEVED. THE SEPARATED TIP WAS THEN SURGICALLY REMOVED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA; HOWEVER, A CLINICALLY SIGNIFICANT DELAY WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 21091781 ↗
• MalfunctionMar 7, 2024Material Separation; Material Separation

  SUBSEQUENTLY, IT WAS NOTED THAT THAT NO PIECE OF THE GUIDE WIRE LEFT IN THE ANATOMY AND PER DEVICE RETURN IT WAS NOTED THAT THE ENTIRE LENGTH OF THE GUIDE WIRE WAS RETURNED; HOWEVER, SEPARATED FROM THE DISTAL CORE AND SHAPING RIBBON FROM THE SOLDER TIP. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 18862434 ↗
• InjuryFeb 8, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE HI-TORQUE BALANCE HEAVYWEIGHT HYDRO 014 GUIDE WIRE WAS NOTED TO HAVE CRUMBLING COATING (TEFLON COATING) DURING AN UNSPECIFIED PROCEDURE. IT CANNOT BE CONFIRMED THAT NO FOREIGN MATERIAL REMAINS IN THE ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18672804 ↗
• InjuryDec 8, 2023Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT WAS TO TREAT THE LEFT UPPER PULMONARY VEIN. THE 014 BALANCE HEAVYWEIGHT HYDRO GUIDE WIRE WAS PLACED AND A BALLOON WAS ADVANCED OVER THE GUIDE WIRE; HOWEVER, SOME RESISTANCE WAS FELT AND WHEN REMOVING THE BALLOON RESISTANCE WAS FELT AGAIN WITH THE GUIDE WIRE. DURING REMOVAL OF THE GUIDE WIRE THROUGH THE CATHETER SOME RESISTANCE WAS NOTED AND UNDER FLUOROSCOPY THE TIP SEPARATED, THE SEPARATION PORTION WAS REMOVED VIA SNARE. ANOTHER 0.014 HEAVY WEIGHT WIRE WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18297651 ↗
• InjuryNov 8, 2023Break; Difficult to Remove; Stretched; Difficult to Advance; Break; Difficult to Remove; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE TIP OF THE BALANCE HEAVYWEIGHT (BHW) GUIDE WIRE MET RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND DURING REMOVAL THE END OF THE WIRE WAS STUCK AND BEGAN TO UNRAVEL AS IT WAS PULLED BACK. A NON-ABBOTT CATHETER WAS PLACED OVER THE GUIDE WIRE WITH THE SUPPORT OF A RUNTHROUGH GUIDE WIRE AND ADVANCED DISTALLY TO ALLOW THE BHW GUIDE WIRE TO BE SLOWLY REMOVED WITH THE CATHETER. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18096888 ↗
• MalfunctionAug 28, 2023Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. THE HI-TORQUE BALANCE HEAVYWEIGHT HYDRO GUIDE WIRE CROSSED THE LESION; HOWEVER, THE WIRE WAS NOTED TO BE FRACTURED AND THE COILS STRETCHED. THE DEVICE WAS REMOVED SUCCESSFULLY. 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 17632576 ↗
• MalfunctionAug 18, 2023Difficult or Delayed Positioning; Off-Label Use; Difficult or Delayed Positioning; Off-Label Use

  IT HAS BEEN REPORTED THE PROCEDURE WAS IN THE SUBCLAVIAN VEIN WITH NO STENOSIS OR TORTUOSITY. THE HI-TORQUE 014 BHW HYDRO 190CM GUIDE WIRE AND THE HT POWERTURN 190CM GUIDE WIRE COULD NOT BE SEEN DURING PROCEDURE. THE RADIOPACITY TIP MARK OF BOTH GUIDE WIRES COULD NOT BE VISUALIZED. ANOTHER HT BHW GUIDE WIRE WAS USED IN THE PROCEDURE. 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 17574712 ↗
• InjuryNov 8, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN RIGHT ILIAC ARTERY. DURING THE PROCEDURE, THE DISTAL PORTION OF THE HI-TORQUE 014 BHW HYDRO 190CM GUIDEWIRE (GW) BROKE IN THE CHEST / ABDOMEN OF THE PATIENT AND WAS SUCCESSFULLY SNARED AND RETRIEVED. THE PATIENT WAS ADMITTED FOR ADDITIONAL OBSERVATION. THERE WAS NO ADVERSE PATIENT SEQUELA. USER FACILITY MEDWATCH (B)(4) REPORT RECEIVED THAT STATES "WIRE BREAKAGE IN THE CHEST AND ABDOMEN RETRIEVED USING FOREIGN BODY RETRIEVAL DEVICE. FINALLY ATTEMPT TO RECANALIZATION OF THE SUPERIOR VENA CAVA WAS UNSUCCESSFUL. ATTEMPT TO RECANALIZED THE RIGHT SUBCLAVIAN VEIN TO THESE SUPERIOR VENA CAVA WAS UNSUCCESSFUL. RIGHT UPPER EXTREMITY MIDLINE PLACEMENT 20 CM LENGTH WITH THE TIP IN THE SUPERIOR VENA CAVA." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15757208 ↗
• InjuryApr 26, 2022Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE ILIAC ARTERY WITH NO CALCIFICATION AND NO TORTUOSITY. THE HT BALANCE HEAVYWEIGHT GUIDE WIRE WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. HOWEVER, DURING WITHDRAWAL THERE WAS RESISTANCE WITH THE GUIDING CATHETER AND THE TIP SEPARATED. A SNARE DEVICE WAS USED TO RETRIEVE THE SEPARATED TIP. THERE WAS NOTHING LEFT IN THE PATIENT ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14209312 ↗
• MalfunctionNov 24, 2020Difficult to Remove; Material Separation; Deformation Due to Compressive Stress; Difficult to Remove; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO INCREASE THE SIZE OF A CENTRAL SHUNT NEAR THE AORTA AND PULMONARY. A BALANCE HEAVYWEIGHT HYDRO GUIDE WIRE WAS ADVANCED WITH A NON-ABBOTT BALLOON. RESISTANCE WAS FELT BETWEEN THE GUIDE WIRE AND BALLOON DURING REMOVAL, AND THE PROXIMAL CORE OF THE GUIDE WIRE BECAME BENT. WHILE OUTSIDE THE ANATOMY, THE PROXIMAL CORE BECAME SEPARATED, AND THE SEPARATED PORTION WAS SIMPLY REMOVED 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 Consequences Or Impact To Patient

  MAUDE report 10891807 ↗

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