HI-TORQUE BALANCE MIDDLEWEIGHT 1001782Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648013843), received between Jan 8, 2019 and Jun 30, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2025Material Separation; Failure to Advance; Difficult to Advance; Material Separation; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HIGHLY CALCIFIED LESION IN THE RIGHT PERONEAL ARTERY. THE BMW GUIDE WIRE WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION. THE GUIDE WIRE WAS REMOVED AND SET ASIDE. LATER IN THE PROCEDURE THE GUIDE WIRE WAS ADVANCED AGAIN WITH A CATHETER HOWEVER THE PHYSICIAN FELT AN ODD RESPONSE FROM THE GUIDE WIRE AND NOTICED THE GUIDE WIRE HAD SEPARATED INSIDE THE CATHETER. THE CATHETER WAS REMOVED WITH BOTH PIECES OF THE GUIDE WIRE INSIDE. ANOTHER BMW 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 22358049 ↗
• InjuryAug 29, 2022Entrapment of Device; Material Separation; Stretched; Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Entrapment of Device; Material Separation; Stretched; Improper or Incorrect Procedure or Method; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A BIFURCATION LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE TO HEAVY CALCIFICATION AND >70% STENOSIS. AFTER IMPLANTATION OF THE STENT, THE HI-TORQUE (HT) BALANCE MIDDLE WEIGHT (BMW) GUIDE WIRE BECAME JAILED AND WHEN PULLED IT WAS PULLED BACK, THE GUIDE WIRE BECAME TRAPPED. IT WAS NOTED TO BE UNCOILED [UNRAVELED] AND THE TIP SEPARATED INSIDE THE ANATOMY. THE PROCEDURE WAS DONE UNDER FLUOROSCOPY BUT NO CINE IMAGES WERE TAKEN. ATTEMPTED TO SNARE THE SEPARATED TIP BUT WAS UNSUCCESSFUL AND WAS LEFT IN THE BODY. NO FINAL IMAGES WERE TAKEN OF THE MATERIAL LEFT IN THE PATIENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15311022 ↗
• InjuryFeb 17, 2021Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED:FORCE WAS APPLIED DURING DEVICE REMOVAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11341105 ↗
• MalfunctionSep 24, 2019Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND CHRONIC TOTAL OCCLUSION LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. A 014 BMW GUIDE WIRE WAS BEING ADVANCED INTO A MICRO-CATHETER; HOWEVER, RESISTANCE BETWEEN THE DEVICES WAS FELT AND THE GUIDE WIRE SEPARATED. THE SEPARATED GUIDE WIRE REMAINED IN THE MICRO-CATHETER AND WERE REMOVED AS A UNIT. A NEW UNSPECIFIED GUIDE WIRE AND A NEW MICRO CATHETER WERE 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 9111956 ↗
• InjuryJan 8, 2019Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE BALANCE MIDDLE WEIGHT (BMW) GUIDE WIRE AS ADVANCED TO THE HEAVILY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). THERE WAS RESISTANCE ADVANCING RAPID EXCHANGE BALLOON DILATATION CATHETERS (BDC) OVER THIS WIRE, SO THE PLAN WAS TO SWITCH THIS BMW OUT FOR A MORE SUPPORTIVE WIRE. AN OTW BDC WAS LOADED OVER THIS BMW AS A PLACEHOLDER FOR THE OTHER WIRE. DURING ATTEMPTS TO REMOVE THE BMW, RESISTANCE WAS MET AND THE DISTAL TIP OF THE BMW SEPARATED IN THE RCA. DEVICE INTERACTION WITH THE BDC ALONG WITH THE HEAVY CALCIUM WAS SUSPECTED TO HAVE CAUSED THE TIP SEPARATION OF THE BMW GUIDE WIRE. ATTEMPTS TO REMOVE THE BMW TIP WITH A SNARE WERE MADE, BUT WERE UNSUCCESSFUL. THE TIP WAS LODGED IN THE CALCIUM OVER AN AREA THAT WAS INTENDED TO BE TREATED WITH A STENT. A 3.0X12 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE RCA COVERING THE SEPARATED TIP OF THE BMW. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8228321 ↗