HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL IIRecalls & reported problems across all models

We found 6 models of HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 478 adverse event reports in the FDA's MAUDE database, received between Aug 8, 2016 and Sep 17, 2026 — classified as 153 injuries, 325 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (235 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 II problems

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II models

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

• HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664

  WIRE, GUIDE, CATHETER
  321 reports
• HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664J

  WIRE, GUIDE, CATHETER
  78 reports
• HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009666J

  WIRE, GUIDE, CATHETER
  41 reports
• HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009665

  WIRE, GUIDE, CATHETER
  21 reports
• HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009666

  WIRE, GUIDE, CATHETER
  15 reports
• HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009665J

  WIRE, GUIDE, CATHETER
  2 reports

Recent HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II adverse event reports

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

• MalfunctionSep 17, 2026Material Separation

  It was reported that the Hi-Torque (HT) Balance MiddleWeight (BMW) Universal II guidewire was removed from the coil dispenser and broke in two parts by the distal part joint by the junction while inserting in the introducer needle. Another HT BMW Universal II was used to complete the procedure. There was no patient involvement 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 50797543 ↗
• InjurySep 9, 2026Material Separation; Difficult to Advance

  It was reported that the procedure was to treat a lesion in an unspecified artery. The HT BMW Universal II guide wire (GW) was advanced with resistance due to the anatomy. The GW was used in the procedure; however, after removal of the GW, the distal portion of the GW was noted to have separated in the patient's radial artery. An attempt was made to retrieve GW fragment; however, the attempt was unsuccessful. Therefore, the fragment remains in the patient and the procedure was then completed through an alternative vascular access site. A radial compression band was applied. A clinically significant delay was reported. No additional information was provided.

  Patient problems: Foreign Body In Patient

  MAUDE report 50697936 ↗
• MalfunctionAug 26, 2026Difficult to Insert; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50458228 ↗
• MalfunctionAug 18, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50306003 ↗
• InjuryAug 11, 2026Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  It was reported that the procedure was to treat a heavily tortuous right radial artery. A Hi-Torque VersaTurn guide wire and HT BMW Universal II guide wire were introduced and advanced through the tortuous segment. It was noted that the BMW guide wire met resistance with the anatomy during advancement. Upon removal, resistance was noted due to the BMW guide wire winding, and force was applied. The tip separated; therefore, the right femoral artery was successfully accessed, and a 6F sheath was placed. A snare device was advanced through the sheath, and the separated tip was successfully retrieved. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50214288 ↗
• MalfunctionAug 10, 2026Difficult to Remove; Material Separation; Difficult to Advance

  It was reported that the procedure was to treat a moderately calcified, moderately tortuous left anterior descending coronary artery. During advancement of the HT Balance MiddleWeight Universal II guide wire, resistance was met due to anatomy. Upon withdrawal, resistance was also met due to anatomy and the guide wire fractured within the guiding catheter. The guiding catheter, along with the fractured guide wire were simply withdrawn and removed from the patient. An image provided show that the tip and coils of the guide wire appear to be separated. 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 50195829 ↗
• InjuryJul 29, 2026Material Separation

  It was reported that the procedure was to treat a lesion in the radial artery. The 190 cm HT BMW Universal II guide wire was advanced; however, the core separated at the weld point and remained in the brachial artery. A snare was used to retrieve the separated piece. 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 50073391 ↗
• MalfunctionJul 28, 2026Difficult to Remove; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059533 ↗
• MalfunctionJul 28, 2026Product Quality Problem; Difficult to Remove; Difficult to Advance

  It was reported that resistance was met inserting and withdrawing the BMW Universal II guide wire through the introducer needle. The proximal end of the guide wire felt like it was embossed, preventing the guide wire from advancing. The same issue occurred with two additional BMW Universal II guide wires. 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 50053336 ↗
• MalfunctionJul 28, 2026Product Quality Problem; Difficult to Remove; Difficult to Advance

  It was reported that resistance was met inserting and withdrawing the BMW Universal II guide wire through the introducer needle. The proximal end of the guide wire felt like it was embossed, preventing the guide wire from advancing. The same issue occurred with two additional BMW Universal II guide wires. 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 50053290 ↗
• MalfunctionJul 28, 2026Product Quality Problem; Difficult to Remove; Difficult to Advance

  It was reported that resistance was met inserting and withdrawing the BMW Universal II guide wire through the introducer needle. The proximal end of the guide wire felt like it was embossed, preventing the guide wire from advancing. The same issue occurred with two additional BMW Universal II guide wires. 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 50053280 ↗
• MalfunctionJul 6, 2026Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE DIAGONAL ARTERY. THE 3X38MM XIENCE SIERRA STENT WERE SUCCESSFULLY IMPLANTED AT THE TARGET LESION. HOWEVER, WHEN ATTEMPTING TO REMOVE THE BMW UNIVERSAL II GUIDE WIRE (GW), THE GW BECAME ENTANGLED WITH THE SECOND STENT DELIVERY SYSTEM (SDS) AND BROKE INTO TWO PARTS. THE SEPARATED GW WAS REMOVED WITH THE SDS AS A SINGLE UNIT. 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 25719574 ↗
• MalfunctionMar 4, 2026Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS MID RIGHT CORONARY ARTERY LESION WITH 80% STENOSIS. THE HT BMW UNIVERSAL II 190 CM GUIDE WIRE WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE GUIDE WIRE WAS STICKING TO THE IMAGING CATHETER. BOTH THE GUIDE WIRE AND CATHETER WERE REMOVED SEPARATELY WITHOUT ISSUE. A NEW WHISPER 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 24514380 ↗
• MalfunctionFeb 12, 2026Product Quality Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE HT BMW UNIVERSAL II 190CM GUIDE WIRE (GW)WAS USED IN THE PROCEDURE WITH AN UNSPECIFIED BALLOON DILATATION CATHETER (BDC); HOWEVER, WHEN ATTEMPTING TO REMOVE THE BDC, THE GW BECAME STUCK TO THE INNER LUMEN OF THE BDC. THEREFORE, THE BDC AND GW HAD TO BE REMOVED AS A SINGLE UNIT. IT WAS NOTED THAT THE OUTER DIAMETER OF THE GW (POLYMER COATING AREA) SEEMS TO QUICKLY INCREASE DUE TO THE BODY TEMPERATURE AND ADHERES TO THE INNER LUMEN OF THE BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW UNSPECIFIED BALLOON CATHETER AND AN UNSPECIFIED GUIDEWIRE. 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 24322982 ↗
• MalfunctionFeb 4, 2026Material Separation

  IT WAS REPORTED THAT WHEN REMOVING THE BMW UNIVERSAL II GUIDE WIRE FROM THE PACKAGING, IT WAS NOTED THE GUIDE WIRE WAS FRACTURED. ANOTHER GUIDE WIRE WAS USED TO CONTINUE 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 24258633 ↗

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