HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Recalls & reported problems

Summary

The FDA's MAUDE database contains 321 adverse event reports that list this exact device (DI 08717648118715), received between Aug 8, 2016 and Aug 11, 2026 — classified as 99 injuries, 222 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (155 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 25 most recent of 321 reports, in the reporter's own words as published by the FDA.

• 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 The guiding catheter, along with the fractured guide wire were simply withdrawn and removed from the patient.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 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 ↗
• MalfunctionFeb 2, 2026Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE BMW UNIVERSAL II GUIDE WIRE WAS ADVANCED TO THE TARGET LESION HOWEVER AFTER STENT IMPLANTATION, RESISTANCE OCCURRED DURING THE INSERTION OF THE NC BALLOON CATHETER AND THE DEVICES ADHERED TOGETHER. SINCE THE BALLOON CATHETER COULD NOT BE REMOVED, BOTH DEVICES WERE REMOVED TOGETHER. OUTSIDE THE ANATOMY THE DEVICES WERE ABLE TO BE SEPARATED HOWEVER DAMAGE WAS NOTED TO THE POLYMER OF THE GUIDE WIRE. 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 24240064 ↗
• MalfunctionFeb 2, 2026Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY. THE BMW UNIVERSAL II GUIDE WIRE WAS ADVANCED TO THE TARGET LESION HOWEVER RESISTANCE WAS ENCOUNTERED ADVANCING A STENT DELIVERY SYSTEM (SDS). ADDITIONALLY, RESISTANCE WAS MET DURING INSERTION OF A NC BALLOON CATHETER AND THE CATHETER STUCK TO THE POLYMER COATING OF THE GUIDE WIRE. THE DEVICE WERE REMOVED TOGETHER. ANOTHER GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. OUTSIDE THE ANATOMY THE DEVICES WERE ABLE 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 24239822 ↗
• InjuryJan 9, 2026Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL MID RIGHT CORONARY ARTERY (RCA) WITH 95% STENOSIS. DURING STENT PLACEMENT, IT WAS NOTED THAT THE BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE WAS NOTED TO SEPARATE. NO RESISTANCE WAS NOTED. THE TAIL END WAS WITHDRAWN BUT A PIECE REMAINS IN THE PATIENT. THE DEVICE WAS IMMEDIATELY REPLACED. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24020399 ↗
• MalfunctionDec 29, 2025Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A TORTUOUS LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE (GW) WAS ADVANCED WITH RESISTANCE NOTED WITHIN THE GUIDING CATHETER AND THE PREVIOUSLY DEPLOYED STENT. AFTER PASSING THE STENT SITE, THE GW COULD NOT BE ADVANCED ANY FURTHER. A BALLOON CATHETER WAS ADVANCED OVER THE GW HOWEVER RESISTANCE WAS MET AND THE CATHETER BECAME TRAPPED ON THE GW. FORCE WAS APPLIED AND THE GW BROKE INSIDE THE BALLOON CATHETER. THE BALLOON CATHETER WAS WITHDRAWN FROM THE ANATOMY WITH THE BROKEN GW INSIDE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL DEVICES. 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 23911976 ↗
• MalfunctionDec 22, 2025Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT WHEN THE 190CM HT BMW UNIVERSAL II GUIDE WIRE WAS REMOVED FROM THE DISPENSER COIL, DAMAGE WAS NOTED. A PHOTO RECEIVED SHOWS THE DISTAL END OF A WIRE WHICH APPEARS TO BE SIGNIFICANTLY UNRAVELED INDICATING A BROKEN CORE. THERE WAS NO DEVICE USE OR 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 23865959 ↗
• MalfunctionDec 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT UPON OPENING THE PACKAGING OF THE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE, THE WIRE WAS FOUND TO BE SEPARATED. THEREFORE, THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23811326 ↗
• MalfunctionDec 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE HT BMW UNIVERSAL II 190CM GUIDE WIRE (GW), THE GW CORE WAS NOTED TO BE SEPARATED INTO TWO PIECES. ANOTHER HT BMW UNIVERSAL II 190CM GW WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759575 ↗
• MalfunctionDec 1, 2025Peeled/Delaminated; Difficult to Remove; Peeled/Delaminated; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH 90% STENOSIS. A BALANCE MIDDLEWEIGHT UNIVERSAL (BMW) II GUIDE WIRE WAS ADVANCED TO THE LESION AND PRE-DILATATION WAS PERFORMED WITH A 1.5X10 MM SEMI-COMPLIANT BALLOON. A 3.5X16 MM NON-ABBOTT STENT WAS IMPLANTED AND POST-DILATATION WAS PERFORMED WITH A NON-COMPLIANT BALLOON. AT THIS POINT THE BMW UNIVERSAL II GUIDE WIRE BECAME STUCK AND WAS DIFFICULT TO REMOVE AND THE POLYMER COVER PEELED OFF. AFTER MULTIPLE ATTEMPTS THE WIRE WAS REMOVED AND THE SEPARATED POLYMER WAS REMOVED WITH THE WIRE. 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 23686752 ↗
• MalfunctionDec 1, 2025Peeled/Delaminated; Difficult to Remove; Peeled/Delaminated; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT CIRCUMFLEX CORONARY ARTERY. A BALANCE MIDDLEWEIGHT UNIVERSAL (BMW) II GUIDE WIRE WAS ADVANCED TO THE LESION AND PRE-DILATATION WAS PERFORMED WITH A SEMI-COMPLIANT BALLOON. A 3.5X13 MM NON-ABBOTT STENT WAS IMPLANTED AND POST-DILATATION WAS PERFORMED WITH A NON-COMPLIANT BALLOON. AT THIS POINT THE BMW UNIVERSAL II GUIDE WIRE BECAME STUCK WITH THE BALLOON AND WAS DIFFICULT TO REMOVE AND THE POLYMER COVER PEELED OFF. AFTER MULTIPLE ATTEMPTS THE WIRE WAS REMOVED AND THE PIECE OF POLYMER WAS ALSO REMOVED AT THE SAME TIME. 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 23686700 ↗
• MalfunctionNov 24, 2025Break; Difficult to Remove; Difficult to Advance; Break; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN ATTEMPTING TO REMOVE THE UNSPECIFIED OPTICAL COHERENCE TOMOGRAPHY (OCT) CATHETER RESISTANCE WAS MET WITH THE HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE. THE GUIDE WIRE SPIRALED AND BECAME STUCK. THE GUIDE WIRE WAS REMOVED INDEPENDENTLY. AN UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS 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 23638843 ↗
• MalfunctionNov 20, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE BMW UNIVERSAL II GUIDE WIRE CROSSED THE LESION FOLLOWED BY PRE-DILATATION WITH A BALLOON CATHETER AND DEPLOYMENT OF A DRUG ELUTING STENT. POST DILATATION WAS PERFORMED WITH A NC BALLOON HOWEVER AFTER THAT THE BMW UNIVERSAL II GUIDE WIRE BECAME STUCK WITH THE NC CATHETER AND THE POLYMER SEPARATED. AFTER SEVERAL ATTEMPTS THE GUIDE WIRE WAS ABLE TO BE REMOVED FROM THE CATHETER. THE SEPARATED POLYMER WAS ABLE TO BE REMOVED FROM THE PATIENT WITH THE BALLOON CATHETER. 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 23605947 ↗
• MalfunctionNov 20, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT CIRCUMFLEX ARTERY. THE BMW UNIVERSAL II GUIDE WIRE CROSSED THE LESION FOLLOWED BY PRE-DILATATION WITH A BALLOON CATHETER AND DEPLOYMENT OF A DRUG ELUTING STENT. POST DILATATION WAS PERFORMED WITH A NC BALLOON HOWEVER AFTER THAT THE BMW UNIVERSAL II GUIDE WIRE BECAME STUCK WITH THE NC CATHETER AND THE POLYMER SEPARATED. AFTER SEVERAL ATTEMPTS THE GUIDE WIRE WAS ABLE TO BE REMOVED FROM THE CATHETER. THE SEPARATED POLYMER WAS ABLE TO BE REMOVED FROM THE PATIENT WITH THE BALLOON CATHETER. 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 23605910 ↗
• MalfunctionNov 20, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE BMW UNIVERSAL II GUIDE WIRE CROSSED THE LESION FOLLOWED BY PRE-DILATATION WITH A BALLOON CATHETER AND DEPLOYMENT OF A DRUG ELUTING STENT. POST DILATATION WAS PERFORMED WITH A NC BALLOON HOWEVER AFTER THAT THE BMW UNIVERSAL II GUIDE WIRE BECAME STUCK WITH THE NC CATHETER AND THE POLYMER PEELED OFF. AFTER SEVERAL ATTEMPTS THE GUIDE WIRE WAS ABLE TO BE REMOVED FROM THE CATHETER. THE PEELED POLYMER WAS ABLE TO BE RETRIEVED FROM THE PATIENT. 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 23605866 ↗
• InjuryNov 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY. DURING USE OF THE BMW UNIVERSAL II GUIDE WIRE, IT SEPARATED AND THE SEPARATION PORTION COULD NOT BE RETRIEVED FROM THE ANATOMY. THREE ADDITIONAL BMW UNIVERSAL II GUIDE WIRES WERE ALSO USED DURING THE PROCEDURE WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23580705 ↗
• MalfunctionNov 4, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY CALCIFIED, LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. THE 190CM HI-TORQUE BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE CROSSED THE LESION AND ROTABLATION WAS PERFORMED. AN UNSPECIFIED DRUG-ELUTING STENT WAS DEPLOYED AND AN UNSPECIFIED NON-COMPLIANT (NC) BALLOON WAS USED FOR POST DILATATION. DURING REMOVAL THE GUIDE WIRE BECAME STUCK WITH THE BALLOON BUT WAS ULTIMATELY REMOVED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF ANOTHER 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 23466649 ↗
• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED IN A GENERAL COMMENT THAT THE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE BROKE BUT DID NOT SEPARATE INTO TWO PIECES DURING USE. THE DEVICE WAS REMOVED WHEN IT WAS NOTED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425613 ↗
• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED IN A GENERAL COMMENT THAT THE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE BROKE BUT DID NOT SEPARATE INTO TWO PIECES DURING USE. THE DEVICE WAS REMOVED WHEN IT WAS NOTED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417543 ↗
• MalfunctionOct 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN REMOVING THE BMW UNIVERSAL II GUIDE WIRE FROM THE COIL DISPENSER, THE TIP WAS FOUND TO BE SPLIT; THEREFORE THE DEVICE WAS NOT USED. 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 23357049 ↗