HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009666Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648118739), received between May 8, 2018 and Aug 18, 2026 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50306003 ↗
• InjuryJan 28, 2026Difficult to Remove; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HIGHLY CALCIFIED LESION IN THE DISTAL CIRCUMFLEX (CX) ARTERY. A GUIDELINE WAS ADVANCED OVER THE BMW UNIVERSAL II GUIDE WIRE WHICH WAS PLACED IN THE CX. A 2.25X33MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED HOWEVER COULD NOT ADVANCE. WHEN PULLING BACK THE SDS, THE STENT BECAME STUCK AND FELT LIKE IT WAS GOING TO DISLODGE FROM THE BALLOON. THE WHOLE SYSTEM WAS REMOVED WITH FORCE WHEN IT WAS NOTED THE DISTAL PART OF THE GUIDE WIRE HAD SEPARATED. THE SEPARATED PORTION REMAINED IN THE DISTAL CX AS NO ATTEMPTS WERE MADE TO RETRIEVE THE WIRE. 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 24199994 ↗
• InjuryMar 12, 2024Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CALCIFIED LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. DURING USE, THE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. AN UNSPECIFIED STENT WAS IMPLANTED IN ANOTHER BRANCH AND JAILED THE GUIDE WIRE. THERE WAS RESISTANCE DURING REMOVAL AND FORCE WAS APPLIED. THE GUIDE WIRE TIP SEPARATED AND WAS ATTEMPTED TO BE REMOVED BY SNARE BUT WAS UNSUCCESSFUL. THE TIP REMAINS FREE FLOATING IN THE PATIENT. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18888078 ↗
• MalfunctionAug 9, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION, THE HT BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE (GW) WAS BEING REMOVED FROM THE HOOP TRAY WHEN THE WIRE SEPARATED IN THE MIDDLE PART, IN TWO PIECES. ANOTHER SAME SIZE BMW GUIDE WIRE WAS USED SUCCESSFULLY FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17491328 ↗
• InjuryApr 21, 2023Difficult to Remove; Material Separation; Stretched; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Stretched; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A DRUG ELUTING STENT WAS PLACED AND UPON REMOVAL OF THE BALANCE MIDDLE WEIGHT GUIDE WIRE, THE WIRE LOOKED FRAYED AND A PART OF THE WIRE WAS SEEN ON THE CONTROL ANGIOGRAPHY; INDICATING THE DEVICE SEPARATED INTO TWO PIECES. THE PHYSICIAN STATED IT COULD BE DUE TO HIS HANDLING. THE SEPARATED PIECE WAS NOT RETRIEVED AND IS FREE FLOATING IN THE CORONARY ARTERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16791553 ↗
• InjuryApr 10, 2023Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method

  MEDWATCH FORM RECEIVED. REPORTED AS [WHILE STENTING, WIRE BECAME JAILED BEHIND STENT. WIRE BROKE WHILE TRYING TO REMOVE IT.] IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE RIGHT POSTERIOR DESCENDING ARTERY (RPDA). THE HT BMW UNIVERSAL II GUIDEWIRE (GW) WAS USED IN THE PROCEDURE; HOWEVER, THE GW BECAME JAILED BEHIND A STENT. THE TIP OF THE GW BECAME SEPARATED WHEN FIRM EFFORT WAS APPLIED DURING REMOVAL. THE PATIENT WENT UNDER OPEN HEART SURGERY TO REMOVE THE JAILED TIP OF THE GW AT ANOTHER FACILITY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709956 ↗
• MalfunctionMar 17, 2023Break; Difficult to Remove; Stretched; Difficult to Advance; Break; Difficult to Remove; Stretched; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY THAT IS 80% STENOSED. THE HT UNIVERSAL II GUIDE WIRE WAS ADVANCED AND ATTEMPTED TO BE RETRACTED HOWEVER THE GUIDE WIRE BECAME STUCK. RESISTANCE WITH ANATOMY WAS NOTED DURING ADVANCEMENT AND DURING REMOVAL OF DEVICE. AFTER REMOVAL IT WAS NOTED THE COILS WERE STRETCHED AND IT APPEARED THE CORE HAD SEPARATED. ANOTHER GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566506 ↗
• InjurySep 1, 2021Difficult to Remove; Stretched; Difficult to Remove; Stretched

  SUBSEQUENT TO THE INITIALLY FILED REPORT A USER FACILITY MEDWATCH WAS RECEIVED WHICH REPORTED: TIP OF WIRE UNRAVELED DURING SHAPING BEFORE ENTERING THE BODY-HAPPENED ON TWO WIRES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408256 ↗
• InjuryAug 31, 2021Difficult to Remove; Material Separation; Stretched; Difficult to Remove; Material Separation; Stretched

  SUBSEQUENT TO THE INITIALLY FILED REPORT A USER FACILITY MEDWATCH WAS RECEIVED: TIP OF WIRE UNRAVELED DURING SHAPING BEFORE ENTERING THE BODY-HAPPENED ON TWO WIRES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12402799 ↗
• InjuryAug 31, 2021Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED, RIGHT CORONARY ARTERY. THE HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE (BMW) WAS ADVANCED WITHOUT ISSUE HOWEVER, DURING REMOVAL OF THE GUIDE WIRE, RESISTANCE WAS FELT. IT IS UNKNOWN WHY RESISTANCE WAS FELT. THE SHAFT AND TIP COILS UNRAVELED. A BALLOON WAS ADVANCED TOWARD THE END OF THE GUIDE WIRE, THE BALLOON WAS INFLATED, AND THE GUIDE WIRE WAS ABLE TO BE REMOVED. THE GUIDE WIRE REMAINED IN ONE PIECE. THE PROCEDURE WAS COMPLETE AT THIS TIME, NO ADDITIONAL DEVICES WERE NEEDED. THERE WERE NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12400764 ↗
• InjuryAug 31, 2021Difficult to Remove; Material Separation; Stretched; Difficult to Remove; Material Separation; Stretched

  SUBSEQUENT TO THE INITIALLY FILED REPORT A USER FACILITY MEDWATCH WAS RECEIVED WHICH REPORTED: TIP OF WIRE UNRAVELED DURING SHAPING BEFORE ENTERING THE BODY-HAPPENED ON TWO WIRES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Vascular Dissection

  MAUDE report 12400456 ↗
• MalfunctionJan 29, 2021Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT WHEN PURGING THE BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE BEFORE USE, THE PROXIMAL PORTION WAS NOTED TO BE BROKEN BUT STILL HELD TOGETHER BY COILS. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW BMW GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11255194 ↗
• MalfunctionApr 8, 2020Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. THE BALANCE MIDDLE WEIGHT GUIDE WIRE (BMW GW) WAS ADVANCED TO THE LESION. THEN THE 3.0X15MM NC TREK BALLOON WAS ATTEMPTED TO BE ADVANCED BUT MET RESISTANCE WITH THE GW. IT WAS THEN ATTEMPTED TO REMOVE THE BALLOON BUT COULD NOT REMOVE FROM THE GUIDE WIRE, THEREFORE WHILE ATTEMPTING TO REMOVE BOTH, THE BALLOON BROKE. RESISTANCE WAS MET WITH BOTH DEVICES DURING REMOVAL. ANOTHER DEVICE WAS USED 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 9938093 ↗
• InjuryOct 8, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT THE BMW UNIVERSAL II GUIDE WIRE WAS ADVANCED TO THE DISTAL PORTION OF THE LESION WHEN THE TIP OF THE GUIDE WIRE SEPARATED. A SNARE WAS USED TO RETRIEVE THE SEPARATED PORTION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7944191 ↗
• InjuryMay 8, 2018Detachment Of Device Component; Difficult To Position; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE OF A MID-LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY THAT WAS NON-TORTUOUS AND MILDLY CALCIFIED. A BALANCE MIDDLEWEIGHT (BMW) II GUIDE WIRE WAS PLACED IN THE DIAGONAL. ANOTHER UNKNOWN GUIDE WIRE WAS ADVANCED IN THE LAD AND THE LESION WAS STENTED ACROSS. WHEN THE BMW GUIDE WIRE WAS BEING REMOVED FROM THE DIAGONAL, IT WAS FOUND TO BE JAILED UNDER A STENT STRUT AND BROKE IN THE GUIDING CATHETER. BOTH GUIDE WIRES WRAPPED UP ON THEMSELVES WHICH WAS GOOD TO HOLD THE BROKEN WIRE STABLE. A BALLOON WAS USED IN THE GUIDING CATHETER AND THE WIRES WERE TRAPPED AND THE SYSTEM WAS PULLED OUT AS A UNIT WITH NO COMPLICATION REPORTED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7495873 ↗