HI-TORQUE BALANCE MIDDLEWEIGHT™ 1011880JRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648144790), received between Apr 19, 2017 and Jun 27, 2024 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE HT BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE WAS ADVANCED THROUGH THE LESION WITHOUT ISSUES; HOWEVER, WHEN IT WAS REMOVED FROM THE PATIENT THE WELD PART OF THE GUIDE WIRE BECAME CAUGHT ON THE INTRODUCER SHEATH. THE GUIDE WIRE WAS ABLE TO BE REMOVED BY SIMPLY PULLING IT OUT. A SECOND HT BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE WAS ADVANCED, BUT THE SAME ISSUE OCCURRED DURING REMOVAL EVEN THOUGH IT WAS A NEW INTRODUCER SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT 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 19625740 ↗
• MalfunctionJun 27, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE HT BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE WAS ADVANCED THROUGH THE LESION WITHOUT ISSUES; HOWEVER, WHEN IT WAS REMOVED FROM THE PATIENT THE WELD PART OF THE GUIDE WIRE BECAME CAUGHT ON THE INTRODUCER SHEATH. THE GUIDE WIRE WAS ABLE TO BE REMOVED BY SIMPLY PULLING IT OUT. A SECOND HT BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE WAS ADVANCED, BUT THE SAME ISSUE OCCURRED DURING REMOVAL EVEN THOUGH IT WAS A NEW INTRODUCER SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT 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 19625670 ↗
• InjuryOct 17, 2023Break; Material Separation; Stretched; Break; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PATIENT WITH OSTIAL DISEASE OF COMMON TRUNK, LEFT ANTERIOR DESCENDING (LAD), AND CIRCUMFLEX (CX) CORONARY ARTERIES. ONE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE WAS POSITIONED IN THE LAD AND OTHER IN THE CX IN A LOOP. THE LESION WAS PRE-DILATATED AND INTRAVASCULAR ULTRASOUND (IVUS) FOUND CALCIUM PRESENT. SHOCKWAVE TECHNIQUE WAS USED AND A 3.5X24MM UNSPECIFIED STENTS WERE IMPLANTED IN THE IVA -TRUNK OSTIAL PART. POST DILATATION WAS PERFORMED WITH A 3.75MM UNSPECIFIED BALLOON. WHEN ATTEMPTING TO REMOVE THE BMW THAT WAS IN THE CX, THERE WAS NO RESISTANCE FELT; HOWEVER, THE TIP COULD BE SEEN ON THE MONITOR ABOUT 1 CENTIMETER JAILED INSIDE AND OUTSIDE THE NEWLY IMPLANTED STENT. IT WAS NOTED DURING REMOVAL THE GUIDE WIRE STRETCHED, FRACTURED AND THEN FULLY SEPARATED AT THE TIP. ANOTHER 2.5X12MM UNSPECIFIED STENT WAS IMPLANTED IN THE OSTIUM OF THE CX BRANCH TO JAIL THE TIP AND TO TREAT THE BRANCH THAT WAS ALREADY SUB-OCCLUDED TO THE OSTIUM. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17951169 ↗
• InjuryJul 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT MAIN (LM), CIRCUMFLEX (CX) BIFURCATION USING A .014 HT BMW ELITE GUIDE WIRE. AFTER DEPLOYMENT OF AN UNSPECIFIED STENT IN THE BIFURCATION, THE DISTAL TIP OF THE GUIDE WIRE SEPARATED. THE GUIDE BROKE BECAUSE IT WAS TRAPPED IN THE DILATATION OF THE BIFURCATION. THE SEPARATED TIP OF THE GUIDE WIRE WAS CAPTURED WITH A LASSO AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT CONSEQUENCE FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17372562 ↗
• InjuryApr 12, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION. THE 3.0X15MM XIENCE STENT DELIVERY SYSTEM (SDS) WAS IMPLANTED IN THE POSTERIOR DESCENDING ARTERY (PDA). THE PHYSICIAN THEN DECIDED TO PERFORM ANGIOPLASTY TO THE POSTERIER LATERAL ARTERY (PLA). THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE WAS USED TO CANNULATE THE PLA. WHEN THE HT BMW ELITE GUIDE WIRE WAS IN PLACE, THE 2.5X8MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY AND WAS REMOVED. THERE WERE NO OTHER ISSUES NOTED. THE HT BMW ELITE GUIDE WIRE WAS REPOSITIONED AND HAD RESISTANCE DURING WITHDRAWAL. A MICROCATHETER WAS ATTEMPTED TO BE USED TO REMOVE THE GUIDE WIRE AND IT WAS AFTER REMOVING THE MICROCATHETER THAT IT WAS NOTED THAT THE PROXIMAL PORTION CLOSE TO THE GUIDE CATHETER FRACTURED AND WAS LEFT IN THE RCA. THE PATIENT WAS SENT IMMEDIATELY TO SURGERY ON (B)(6) 2023 AND AFTER SURGERY WAS ADMITTED TO INTENSIVE CARE. ON (B)(6) 2023, THE PATIENT HAD CARDIORESPIRATORY COMPLICATIONS AND COULD NOT BE TREATED ANY FURTHER DUE TO A "DO NOT RESUSCITATE" (DNR) DOCUMENTATION. THE PATIENT DIED. ANGIOGRAPHY WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16724428 ↗
• MalfunctionNov 1, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED VEIN GRAFT IN THE RIGHT POSTERIOR DESCENDING ARTERY (PDA). THE 014 HT BMW ELITE 190CM GUIDEWIRE (GW) WAS ADVANCED AND USED IN THE PROCEDURE; HOWEVER, AFTER REMOVAL WITHOUT ISSUE, WHILE WIPING THE GW DOWN FOR REUSE, THE GW BROKE IN TWO PIECES. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER BMW GW WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION REGARDING THIS ISSUE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15712322 ↗
• MalfunctionJul 8, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. A 014 HT BMW ELITE GUIDE WIRE (GW) SEPARATED INTO TWO PIECES AT THE CORE, WHILE THE PHYSICIAN TRIED TO INTRODUCE IT INTO THE GUIDE CATHETER BEFORE THE GUIDE WIRE WAS ENTERED INTO THE ANATOMY. 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 14958163 ↗
• InjuryJan 18, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. WHEN ADVANCING A HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE, IT SEPARATED IN TWO PIECES. THE FRAGMENT OF THE BROKEN GUIDE WIRE WAS REMOVED WITH A "LASSO CAPTURE" DEVICE. THE PROCEDURE TIME WAS PROLONGED WITH INCREASED FLUOROSCOPY TIME AND DOSE BUT THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13283048 ↗
• MalfunctionApr 21, 2021Difficult to Insert; Peeled/Delaminated; Difficult to Insert; Peeled/Delaminated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. A BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE WAS ATTEMPTED TO BE INSERTED INTO AN UNSPECIFIED BALLOON CATHETER; HOWEVER, THERE WAS DIFFICULTY AND THE CORE WAS PEELING. ANOTHER BMW ELITE GUIDE WIRE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11700786 ↗
• MalfunctionSep 21, 2020Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MODERATELY CALCIFIED, DISTAL RIGHT CORONARY ARTERY. THE BALANCE MIDDLE WEIGHT (BMW) GUIDE WIRE AND THE 2.25X12MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) SUCCESSFULLY CROSSED THE TARGET LESION. THE SIERRA STENT WAS IMPLANTED WITHOUT ISSUE. HOWEVER, RESISTANCE WAS FELT WITH THE GUIDE WIRE DURING REMOVAL. THE GUIDEWIRE AND THE SDS WERE REMOVED TOGETHER AS A SINGLE UNIT. A BURR COULD BE FELT ON THE RADIOPAQUE TIP OF THE GUIDE WIRE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10563591 ↗
• InjuryJul 10, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE HEAVILY TORTUOUS RIGHT CORONARY ARTERY (RCA). PRIOR TO DILATATION OF THE LESION WITH A BALLOON, THE BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE WAS ADVANCED TO THE SMALL AND TORTUOUS VESSEL WITH A JR4 GUIDING CATHETER AND A LOT OF TORQUE WAS REQUIRED. THERE WAS NO RESISTANCE NOTED, JUST THE TORTUOSITY OF THE VESSEL. ONCE THE BMW WIRE WAS PLACED, IT WAS NOTED THAT THE TIP HAD SEPARATED. THE TIP REMAINS IN THE PATIENT AND THERE WAS NO REPORTED TREATMENT. THE PATIENT IS REPORTEDLY FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10261376 ↗
• MalfunctionOct 20, 2017Detachment Of Device Component; Stretched

  IT WAS REPORTED THAT AT THE END OF THE PROCEDURE, WHEN THE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE WAS REMOVED FROM THE GUIDING CATHETER, IT WAS NOTED THAT THE COILS WERE STRETCHED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS FOUND DURING ANALYSIS OF THE RETURNED DEVICE THAT THE CORE HAD SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6965889 ↗
• MalfunctionApr 19, 2017Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A HT BMW ELITE GUIDE WIRE AND NON-ABBOTT MICRO-CATHETER WERE ADVANCED TO THE LESION; HOWEVER, RESISTANCE BETWEEN THE DEVICES WAS FELT WHEN ATTEMPTING TO REMOVE THE GUIDE WIRE. THE MICRO-CATHETER AND GUIDE WIRE WERE REMOVED TOGETHER AS A SINGLE UNIT. THE GUIDE WIRE REMAINED IN THE MICRO-CATHETER AS IT WAS IMPOSSIBLE TO REMOVE IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT DEVICE. 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 6504593 ↗