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

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 08717648118753), received between Dec 13, 2016 and Sep 17, 2026 — classified as 24 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (41 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 78 reports, 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 ↗
• 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 ↗
• MalfunctionNov 11, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN HE LEFT ANTERIOR DESCENDING ARTERY. THE BMW UNIVERSAL II GUIDE WIRE WAS ADVANCED TO THE TARGET LESION HOWEVER WHEN THE BALLOON CATHETER WAS ADVANCED OVER THE GUIDE WIRE IT BECAME STUCK. DIFFICULTY WAS MET REMOVING THE BALLOON CATHETER THEREFORE THE DEVICES WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON CATHETER AND 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 23521661 ↗
• MalfunctionNov 6, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE HT BMW UNIVERSAL II 190CM J GUIDE WIRE (GW) WAS BEING USED IN THE PROCEDURE; HOWEVER, WHEN ATTEMPTING TO LOAD AN A 3X15MM NC TREK BALLOON DILATATION CATHETER (BDC), FRICTION WAS NOTED AND THE BDC BECAME STUCK WITH GW. THEREFORE, THE GW AND BDC HAD TO BE REMOVED AS A SINGLE UNIT. ANOTHER BMW GW WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487868 ↗
• MalfunctionOct 15, 2025Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD). THE 190CM HT BMW UNIVERSAL II GUIDE WIRE WAS ADVANCED THROUGH A GUIDING CATHETER; HOWEVER, AFTER SMALL PRESSURE WAS FELT, THE PROXIMAL SHAFT SEPARATED FROM THE DISTAL SHAFT. THE SEPARATED PORTION WAS SIMPLY WITHDRAWN AND A NEW BMW UNIVERSAL II GUIDE WIRE WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294139 ↗
• InjuryAug 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THE BMW UNIVERSAL II GUIDE WIRE WAS USED IN THE PATIENT HOWEVER SEPARATED. THE SEPARATED PORTION WAS UNABLE TO BE REMOVED AND REMAINS IN THE PATIENT. PER THE PHYSICIAN THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22700696 ↗
• InjuryJul 29, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  SUBSEQUENTLY AFTER THE INITIAL REPORT HAD ALREADY BEEN FILED, DURING REMOVAL OF THE GUIDE WIRE, THE TIP SEPARATED. AN ATTEMPT WAS MADE TO SNARE IT OUT, HOWEVER, SNARING WAS UNSUCCESSFUL AND THE TIP REMAINS IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22648919 ↗
• MalfunctionJul 18, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 190CM HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE WAS ABLE TO CROSS THE LESION. A 2.5X12MM TREK BALLOON DILATATION CATHETER (BDC) WAS BACKLOADED AND ADVANCED OVER THE GUIDE WIRE BUT MET RESISTANCE. THE TREK BALLOON WAS INFLATED AT THE LESION AND DEFLATED FOR POST-DILATION. DURING REMOVAL OF THE TREK BDC, THE BALLOON STUCK WITH THE GUIDE WIRE AND WAS FORCEFULLY PULLED OUT. IT WAS NOTED THAT DIFFICULT ADVANCEMENT AND REMOVAL WAS DUE TO THE HT BMW UNIVERSAL II GUIDE WIRE. AN UNSPECIFIED GUIDE WIRE WAS USED TO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 22546979 ↗
• MalfunctionMay 1, 2025Break; Difficult to Advance; Material Too Soft/Flexible; Break; Difficult to Advance; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT DE NOVO LESION IN THE CIRCUMFLEX (CX) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE HT BMW UNIVERSAL II 190CM J GUIDE WIRE (GW) WAS ATTEMPTED TO BE USED IN THE PROCEDURE; HOWEVER, DIFFICULTY WAS NOTED DURING ADVANCEMENT WITH THE ANATOMY AND THE INNER CORE OF THE GW SEEMED BROKEN. THIS LED TO POOR MANEUVERABILITY OF THE GW AND LOSS OF SUPPORT. THEREFORE, THE GW WAS REMOVED FROM THE PATIENT. ANOTHER HT BMW UNIVERSAL GW WAS USED TO CONTINUE 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 21943565 ↗
• MalfunctionJan 27, 2025Break; Break

  IT WAS REPORTED THAT DURING ADVANCEMENT OF THE HT BMW UNIVERSAL II GUIDE WIRE (GW) INTO THE GUIDE CATHETER (GC) THROUGH THE INTRODUCER SHEATH, A BREAK WAS NOTED TO HAVE OCCURRED AT THE TRANSITION POINT BETWEEN THE FLOPPY AND RIGID PART OF THE GW. THE GW REMAINED IN ONE PIECE AND WAS REMOVED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED DEVICE. 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 21245654 ↗
• MalfunctionJan 13, 2025Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. DURING STENT PLACEMENT ALONG THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE, COATING ON THE CORE OF THE WIRE WAS NOTED TO HAVE BEEN PEELED. RESISTANCE WAS FELT WITH THE STENT DURING ADVANCEMENT. 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 21145311 ↗
• MalfunctionNov 21, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. THE BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE BECAME STUCK IN THE LUMEN OF THE BALLOON CATHETER DURING ADVANCEMENT AND REMOVAL AND THE DEVICES WERE REMOVED TOGETHER. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747337 ↗
• MalfunctionSep 5, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS STATED THAT THE DEVICES WERE STUCK TOGETHER IN THE CORONARY ARTERY SO THEY WERE REMOVED TOGETHER, AND WHEN THEY REACHED THE GUIDING CATHETER, THEY WERE REMOVED SEPARATELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147193 ↗
• MalfunctionSep 3, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CIRCUMFLEX (RCX) ARTERY. THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE WAS ADVANCED. THE DRAGONFLY OPSTAR IMAGING CATHETER WAS ALSO ADVANCED; HOWEVER, THE IMAGING CATHETER WAS NOTED TO BE STICKING WITH THE GUIDE WIRE. THERE WAS DIFFICULTY ADVANCING AND REMOVAL OF THE CATHETER WITH THE HT BMW GUIDE WIRE. THE DEVICES WERE REMOVED ALTOGETHER AND THEN REMOVED INDEPENDENTLY INSIDE THE GUIDE CATHETER. ANOTHER HT BMW GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. 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 20126746 ↗
• InjuryAug 30, 2024Difficult to Remove; Material Separation; Stretched; Difficult to Remove; Material Separation; Stretched

  SUBSEQUENT TO THE INITIAL REPORT BEING FILED. A MEDWATCH REPORT WAS RECEIVED STATING THE FOLLOWING: "THE BMW UNIVERSAL II WIRE WAS BEING USED FOR AN INTERVENTION. WHEN THE PHYSICIAN TRIED REMOVING THE WIRE, THE TIP BECAME ENTANGLED IN THE STENT STRUTS. AFTER MANY ATTEMPTS AT GETTING THIS WIRE LOSE, IT FRAYED, AND THE TIP DETACHED FROM THE REMAINING WIRE. THE PHYSICIAN WAS NOT ABLE TO RETRIEVE THE WIRE TIP OUT OF THE ARTERY. TO PREVENT ANY COMPLICATIONS, HE SECURED IT IN PLACE BY PINNING IT AGAINST TWO DEPLOYED STENTS." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20112651 ↗
• MalfunctionAug 28, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. DURING USE, THE HT BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE BECAME STUCK INSIDE THE LUMEN OF AN UNSPECIFIED BALLOON DELIVERY SYSTEM. THEREFORE, BOTH DEVICES WERE REMOVED TOGETHER WITHOUT ANY ISSUE. A NON-ABBOTT GUIDE WIRE WAS THEN USED. 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 20091329 ↗
• MalfunctionAug 12, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE LEFT CIRCUMFLEX (CX). REPORTEDLY A BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER A 190CM HT BMW UNIVERSAL II GUIDEWIRE (GW) TO THE LESION; HOWEVER, AFTER THE DILATION OF THE LESION THE DEFLATED BDC WAS NOTED TO BE STUCK ON THE GW DURING REMOVAL. BOTH DEVICES WERE REMOVED AS A SINGLE UNIT AND ANOTHER DEVICE WAS USED TO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19962169 ↗
• MalfunctionAug 6, 2024Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance

  SUBSEQUENT TO THE INITIALLY FILED REPORT, IT WAS REPORTED THAT THE ADVANCEMENT WAS MORE DIFFICULT IN THE ANATOMY AND AFTER ABOUT 30 MINUTES OF THE WIRE BEING IN THE ANATOMY RESISTANCE BEGAN TO BE FELT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19923662 ↗
• InjuryJul 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT RIGHT RADIAL ACCESS WAS OBTAINED AND WHILE ADVANCING A GUIDE CATHETER, RESISTANCE WAS ENCOUNTERED THEREFORE A BMW UNIVERSAL II GUIDE WIRE WAS ADVANCED. DURING REMOVAL OF THE GUIDE WIRE, THE DISTAL PART COMPLETELY SEPARATED IN THE ANATOMY. THE GROIN WAS THEN ACCESSED AND A SECOND GUIDE CATHETER AND A SNARE DEVICE WERE ADVANCED TO COMPLETELY REMOVE THE SEPARATED PART WITHOUT ISSUE. THE PROCEDURE WAS ABORTED WITH POSSIBLE RETURN FOR THE PATIENT ON ANOTHER DATE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804746 ↗
• InjuryMay 23, 2024Difficult to Remove; Material Separation; Stretched; Device Damaged by Another Device; Material Too Soft/Flexible; Difficult to Remove; Material Separation; Stretched; Device Damaged by Another Device; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD TORTUOSITY AND 80% STENOSIS AND THE PROXIMAL OSTIUM OF THE MARGINAL CIRCUMFLEX CORONARY ARTERY WITH HIGH TORTUOSITY AT THE OSTIUM AND 80% STENOSIS. THE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE WAS PLACED IN THE MARGINAL OF THE CIRCUMFLEX CORONARY ARTERY TO PROTECT THE DIAGONAL BRANCH BUT THE GUIDE WIRE WAS JAILED BY A STENT WHICH WAS IMPLANTED. IT WAS RETRACTED FROM THE PATIENT. IT WAS DECIDED TO TREAT THE MARGINAL OF THE CIRCUMFLEX CORONARY ARTERY AND USED A NON-ABBOTT WIRE. THE NON-ABBOTT WIRE CAUSED A VASOSPASM SO THE BMW UNIVERSAL II GUIDE WIRE WAS ADVANCED AGAIN. AN ABNORMAL LOOP [PROLAPSE] WAS NOTED IN THE GUIDE WIRE AND IT WAS ATTEMPTED TO BE REMOVED. DURING REMOVAL, THERE WAS NO RESISTANCE BUT THE GUIDE WIRE BEGAN TO FRAY AND A LONG FILAMENT REACHED THE AORTA. THE TIP SEPARATED AND REMAINED IN THE CORONARY ARTERY. A NON-ABBOTT BALLOON WAS USED TO TRY TO TRAP THE TIP, AS WELL AS A GOOSE NECK SNARE BUT BOTH WERE UNSUCCESSFUL. ON (B)(6) 2024, ANOTHER PROCEDURE WAS PERFORMED USING A GOOSE NECK TO REMOVE THE FILAMENT. THE FILMS WERE ANALYZED AND SAW THAT A LONG TH

  Patient problems: Foreign Body In Patient; Nausea; Transient Ischemic Attack

  MAUDE report 19382829 ↗
• MalfunctionFeb 21, 2024Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THAT WHEN ATTEMPTING TO REMOVE THE HT BMW UNIVERSAL GUIDEWIRE FROM THE PACKAGING, IT WAS NOTED TO BE STUCK TO THE DISPENSER COIL. THE GUIDEWIRE WAS REMOVED WITH FORCE AND BECAME VERY STRETCHED. IT COULD NOT BE CONFIRMED IF THE GUIDEWIRE WAS INTACT WHEN PULLED OUT OF THE PACKAGING [UNRAVELED]. THE DEVICE WAS NOT USED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BMW GUIDEWIRE. 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 18749372 ↗