HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL 1009661Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08717648014345), received between Aug 10, 2016 and Nov 25, 2025 — classified as 8 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL CIRCUMFLEX (CX). THE HI-TORQUE BMW UNIVERSAL GUIDE WIRE (GW) WAS PLACED IN THE 2ND OBTUSE MARGINAL (OM) ARTERY, BUT MOVED MORE DISTAL. TWO XIENCE SKYPOINT STENTS WERE SUCCESSFULLY IMPLANTED IN THE CX TARGET LESION, FOLLOWED BY POST-DILATATION. WHEN CONTRAST WAS INJECTED STAINING WAS NOTED FROM THE OM TO THE 2ND APEX OF THE HEART AND A SMALL PERFORATION WAS NOTED AT THE LOCATION WHERE THE GW WAS PARKED, CAUSING FAST DECOMPOSITION. AN ECHO CARDIOGRAM REVEALED A PERICARDIAL EFFUSION. THE PATIENT WAS SHOWING LOSS OF VITALS AND THE START OF CARDIAC ARREST. THE PHYSICIAN WAS ABLE TO REMOVE BLOOD FROM THE PERICARDIUM, WHILE REINTRODUCING THE PATIENT BLOOD AT THE SAME TIME, WHICH STABILIZED THE PATIENT; HOWEVER, THE PERFORATION WAS NOTED TO NOT BE RESOLVED AND LEAKING WAS STILL NOTED. BALLOON INFLATIONS WERE PERFORMED AT THE PERFORATION, BUT STILL DID NOT SEAL THE PERFORATION. DUE TO THE DISTAL LOCATION AND SIZE OF THE PERFORATION, THE PATIENT WAS NOT A CANDIDATE FOR A COVERED STENT; THEREFORE COILING WAS DONE TO TREAT THE PERFORATION. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT IN STABLE CONDITION. NO ADDI

  Patient problems: Cardiac Arrest; Perforation of Vessels; Pericardial Effusion

  MAUDE report 17674505 ↗
• InjurySep 1, 2023Entrapment of Device; Difficult to Remove; Material Separation; Entrapment of Device; Difficult to Remove; Material Separation

  RECEIVED MEDWATCH MW5119967 WHICH STATES: WE THEN TRIED PULL BACK THE BMW WIRE BUT THE WIRE RADIO-OPAQUE SEGMENT/TIP BECAME WEDGED BEHIND THE STRUTS OF THE STENT THAT WE HAD JUST DEPLOYED. HOWEVER AS WE PULLED THE WIRE THROUGH THE CATHETER, THE TIP OF THE WIRE BROKE LOOSE BEHIND THE STENT BUT DID NOT EMBOLIZE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17671309 ↗
• MalfunctionSep 15, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A ROTO BLADE CATHETER WAS ADVANCED AND ROTABLATION WAS PERFORMED ON THE ARTERY. A 2.5X20MM TREK OTW BALLOON DILATATION CATHETER (BDC) WAS BACKLOADED ONTO THE ROTO BLADE WIRE AND INFLATED ONCE TO 8 ATMOSPHERES (ATMS). THE BDC WAS DEFLATED WITHOUT ISSUES AND THE ROTO BLADE WIRE REMOVED. A HI-TORQUE BMW UNIVERSAL GUIDE WIRE WAS ADVANCED THROUGH THE BDC AND THE BDC WAS INFLATED ONCE AGAIN TO 8 ATMS. THE BDC WAS DEFLATED WITHOUT ISSUES; HOWEVER, WHEN ATTEMPTING TO REMOVE THE BDC FROM THE GUIDE WIRE IT WAS STUCK. BOTH THE BDC AND THE GUIDE WIRE HAD TO BE REMOVED AS A UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW BMW AND TREK BDC. 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 15429556 ↗
• MalfunctionMay 19, 2022Off-Label Use; Material Separation; Off-Label Use; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT LOWER TIBIAL ARTERY THAT WAS NON TORTUOUS AND SLIGHTLY STENOSED. DURING REMOVAL OF AN UNSPECIFIED BALLOON DILATATION CATHETER, THE HI-TORQUE BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL 300CM GUIDE WIRE SEPARATED. THE SEPARATED SEGMENT OF THE GUIDE WIRE WAS IN THE BALLOON CATHETER AND BOTH WERE REMOVED TOGETHER AS A SINGLE UNIT, SO NOTHING WAS LEFT IN THE PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE GUIDE WIRE WAS REPLACED WITH SECOND BMW WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14439248 ↗
• MalfunctionJan 26, 2022Break; Difficult to Remove; Difficult to Advance; Break; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT DURING ADVANCEMENT OF THE HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE RESISTANCE WAS MET WITH ANATOMY AND BECAME STUCK. DURING REMOVAL, THE TIP COILS BECAME STRETCHED "ACCORDION LIKE" AND THE DEVICE WAS REMOVED IN ONE PIECE. 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 13358160 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE PERONEAL ARTERY, 90% STENOSED LESION. A BALANCE MIDDLE WEIGHT GUIDEWIRE SUCCESSFULLY CROSSED THE LESION AND DILATATION WAS PERFORMED USING A NON-ABBOTT DEVICE. THERE WAS NO DEVICE ISSUE OR UNUSUAL RESISTANCE NOTED. REPORTEDLY, DURING USE OF THE BMW, A DISSECTION OCCURRED, RELATED TO THE BMW. THE DISSECTION DID NOT REQUIRE ANY TREATMENT, THE PATIENT REMAINED IN STABLE CONDITION, AND WAS DISCHARGED HOME THAT SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Vascular Dissection

  MAUDE report 13153051 ↗
• InjuryOct 13, 2021Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY. A 300 CM HI-TORQUE BALANCE MIDDLEWEIGHT GUIDEWIRE WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. THEN UPON REMOVAL, RESISTANCE MET WITH THE ANATOMY, AND THE DISTAL TIP OF THE GUIDEWIRE BECAME DETACHED INTO THE LEG. THE PROXIMAL END OF THE GUIDEWIRE WAS REMOVED, AND AN UNSPECIFIED CATHETER WAS ADVANCED AND THE SEPARATED TIP WAS REMOVED WITH A SNARE. THE PROCEDURE CONTINUED AND THE TARGET LESION WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED GUIDEWIRE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624390 ↗
• InjuryAug 2, 2019Material Separation; Material Separation

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: [GUIDE WIRE BROKE DURING PROCEDURE FDA SAFETY REPORT.] NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 7/23/2019: THE CORE SEPARATED IN TWO PIECES DURING ADVANCEMENT. NO RESISTANCE NOTED DURING ADVANCING. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE SEPARATED PORTION VIA SNARE BUT UNSUCCESSFUL AND WAS NOT RETRIEVED AT THIS HOSPITAL. PROCEDURE TIME BECAME PROLONGED. DEVICE WAS NOT EMBEDDED IN VESSEL. PATIENT SENT TO ANOTHER HOSPITAL AND IT IS UNKNOWN IF RETRIEVED THERE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8857792 ↗
• MalfunctionJul 24, 2019Difficult to Remove; Stretched; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS CORONARY INTERVENTION TREATING A LEFT ANTERIOR DESCENDING (LAD), SEVERELY CALCIFIED LESION. THERE WAS NO TORTUOSITY. A BALANCE MIDDLEWEIGHT GUIDE WIRE (BMW) WAS SUCCESSFULLY PLACED AND A 3.0X28MM XIENCE SIERRA STENT WAS SUCCESSFULLY IMPLANTED. DURING BMW REMOVAL, DIFFICULTY WAS ENCOUNTERED AND THE WIRE COILS HAD STRETCHED. THERE WAS NO OBSERVED INTERACTION BETWEEN THE STENT AND BMW AND THE DIFFICULTY REMOVING THE BMW WAS DEEMED DUE TO ANATOMY. THE BMW WAS REMOVED FROM THE PATIENTS ANATOMY WITHOUT FURTHER ISSUES. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8823738 ↗
• MalfunctionNov 15, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A BALANCE MIDDLE WEIGHT UNIVERSAL GUIDE WIRE WAS BEING ADVANCED THROUGH A NON-ABBOTT GUIDING CATHETER WHEN UNDER ANGIOGRAPHY IT LOOKED LIKE THERE WERE TWO GUIDE WIRES IN THE ANATOMY. THE GUIDE WIRE AND THE GUIDING CATHETER WERE REMOVED FROM THE ANATOMY AS A SINGLE UNIT. WHEN THE GUIDE WIRE WAS REMOVED FROM THE ANATOMY IT WAS NOTED THAT THE BMW UNIVERSAL GUIDE WIRE HAD SEPARATED AT THE HYPOTUBE. THE ENTIRE GUIDE WIRE WAS REMOVED AT THE TIME THE GUIDING CATHETER WAS REMOVED. THERE WAS NO RESISTANCE FELT WHEN ADVANCING. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7035615 ↗
• InjuryMar 17, 2017Detachment Of Device Component; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE DISTAL TIBIAL ARTERY THAT WAS MILDLY TORTUOUS. THE HI-TORQUE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS BEING USED WITH A NON-ABBOTT MICRO-CATHETER. WHEN THE BMW WAS BEING REMOVED FROM THE ANATOMY, THE CORE OF THE WIRE SEPARATED IN THE VESSEL. TWO ATTEMPTS WERE MADE TO SNARE THE SEPARATED PORTION OF WIRE BUT WERE BOTH UNSUCCESSFUL. HOWEVER, WHEN THE NON-ABBOTT MICRO-CATHETER WAS BEING REMOVED, THE SEPARATED GUIDE WIRE CAME OUT OF THE ANATOMY WITH THE CATHETER. NOTHING WAS LEFT IN THE PATIENT. ALTHOUGH THERE WAS A 25 MINUTE DELAY IN THE PROCEDURE, IT WAS NOT CLINICALLY SIGNIFICANT. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6415610 ↗
• InjuryAug 10, 2016Detachment Of Device Component; Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED BELOW THE KNEE. THE VESSEL HAD MODERATE TORTUOSITY AND HEAVY CALCIFICATION. AFTER SUCCESSFULLY PLACING THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE, A 2.0 TREK BALLOON WAS ADVANCED OVER THE GUIDE WIRE; HOWEVER, RESISTANCE WAS FELT AND IT STOPPED ADVANCING. AS THE BALLOON CATHETER AND THE GUIDE WIRE WERE STUCK TOGETHER, THEY WERE REMOVED TOGETHER FROM THE ANATOMY, AT WHICH TIME IT WAS OBSERVED THAT THE GUIDE WIRE HAD SEPARATED LEAVING ABOUT 12 INCHES OF THE DISTAL END IN THE ANATOMY. A SNARE DEVICE WAS USED TO CAPTURE AND RETRIEVE THE SEPARATED SEGMENT OF GUIDE WIRE SUCCESSFULLY. A NEW GUIDE WIRE WAS ADVANCED FOR COMPLETION OF THE PROCEDURE. THE SAME 2.0 TREK BALLOON WAS ADVANCED OVER THE GUIDE WIRE, THIS TIME WITHOUT ISSUE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5866667 ↗