HI-TORQUE BALANCE MIDDLEWEIGHT 1001782J-HCRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648026010), received between Jul 6, 2017 and Mar 4, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2024Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS MORE DIFFICULT THAN NORMAL UPON REMOVAL. WHEN THE GUIDE WIRE WAS REMOVED, THE TIP WAS STRIPPED AND DAMAGED, NOTING THAT THE COILS DETACHED FROM THE TIP BUT REMAINS IN ONE PIECE. 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 18831927 ↗
• MalfunctionJan 27, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOUR HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRES HAD RESISTANCE DURING ADVANCEMENT AND GOT STUCK WITH AN UNSPECIFIED NUMBER OF BALLOON DEVICES. THE GUIDE WIRES AND BALLOONS STUCK WERE REMOVED FROM THE ANATOMY. ADDITIONAL GUIDE WIRES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT 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 18592769 ↗
• MalfunctionJun 27, 2023Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Improper or Incorrect Procedure or Method; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A FIBROUS LESION IN THE BYPASS ANOSTOMOSIS BETWEEN THE RIGHT INTERNAL MAMMARY ARTERY AND THE RIGHT CORONARY ARTERY (RCA) WITHOUT CALCIFICATION. A HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) HYDRO GUIDE WIRE WAS INSERTED THAT WAS CUT BY THE PHYSICIAN TO THE LENGTH NEEDED. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE SHEATH AND THE 2.75X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, HOWEVER, THE BALLOON COULD NOT BE INFLATED AT ALL SINCE THE BALLOON WAS POSSIBLY DAMAGED BY THE CUT GUIDE WIRE TIP. THE STENT DISLODGED FROM THE BALLOON IN THE CORONARY BYPASS WHEN ATTEMPTING TO GO IN THE GUIDING CATHETER AND INTERACTED WITH THE TIP OF THE GUIDING CATHETER UPON REMOVAL. A CERTAIN TECHNIQUE HAD TO BE PERFORMED TO REMOVE THE STENT FROM THE BYPASS INCLUDING A LASSO, MULTIPLE GUIDE WIRES AND REMOVAL AS A WHOLE UNIT OF THE GUIDE WIRE, SDS, STENT, AND GUIDING CATHETER THROUGH THE SUBCLAVIAN ARTERY UP TO THE RADIAL ARTERY. THE INTRODUCER SHEATH ALSO HAD TO BE REMOVED. ANOTHER NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELAE AND THE PATIENT WAS DISCHARGED THE NEXT DAY AS PLANNED. ALTHOUGH T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17213638 ↗
• MalfunctionFeb 21, 2022Peeled/Delaminated; Peeled/Delaminated

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES "ABBOTT HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE USED DURING CEREBRAL THROMBECTOMY WAS DAMAGED AND UNUSABLE DURING CASE. COATING PEELED OFF WIRE PRIOR TO IT'S USE. IMPAIRED AND PACKAGING SAVED FOR MANUFACTURER INSPECTION. FDA SAFETY REPORT ID #(B)(4)." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13570159 ↗
• MalfunctionJan 31, 2022Break; Break

  IT WAS REPORTED THAT DURING UNPACKING OF A BALANCE MIDDLEWEIGHT HYDRO GUIDE WIRE, IT WAS NOTED TO BE UNCOILED AT THE TIP. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW 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 13392629 ↗
• MalfunctionDec 16, 2021Defective Component

  ABBOTT HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE USED DURING CEREBRAL THROMBECTOMY WAS DAMAGED AND UNUSABLE DURING CASE. COATING PEELED OFF WIRE PRIOR TO ITS USE. IMPAIRED AND PACKAGING SAVED FOR MANUFACTURER INSPECTION. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026184 ↗
• MalfunctionJan 15, 2021Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A LEFT ANTERIOR DESCENDING ARTERY. A 2.5X28MM XIENCE ALPINE WAS ATTEMPTED TO ADVANCE OVER THE .014 BALANCE MIDDLEWEIGHT HYDRO GUIDE WIRE; HOWEVER, IT BECAME STUCK. BOTH DEVICES WERE SIMPLY REMOVED AS ONE UNIT. ANOTHER UNSPECIFIED STENT AND GUIDE WIRE WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. SUBSEQUENT TO FILING THE INITIAL REPORT, THE FOLLOWING CLARIFICATION WAS RECEIVED: THE 2.5X28MM XIENCE ALPINE WAS THE DEVICE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE AND NOT THE DEVICE THAT BECAME STUCK ON THE BMW GUIDE WIRE. THE DEVICE THAT BECAME STUCK ON THE BMW GUIDE WIRE WAS A NON-ABBOTT STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11179593 ↗
• MalfunctionNov 27, 2017Detachment Of Device Component; Difficult To Position; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS RIGHT CORONARY ARTERY. A BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED TO THE LESION. A 2.25 X 23 OTW XIENCE ALPINE WAS BEING ADVANCED OVER THE GUIDE WIRE WITHOUT RESISTANCE; HOWEVER, THE GUIDE WIRE BACKED OUT SLIGHTLY SO THE PHYSICIAN TRIED TO ADVANCE THE GUIDE WIRE WHEN THERE WAS RESISTANCE WITH THE CATHETER. AN ATTEMPT WAS MADE TO REMOVE THE CATHETER, BUT AT THE GUIDING CATHETER TIP, THERE WAS RESISTANCE AGAIN WITH THE GUIDE WIRE SO THE DEVICES WERE REMOVED FROM THE ANATOMY AS A SINGLE UNIT. OUTSIDE THE ANATOMY, IT WAS NOTED THAT THE GUIDE WIRE TIP HAD SEPARATED AND THE COILS HAD STRETCHED AND SOME OF THEM WERE ENTWINED WITH THE STENT STRUTS. AN ATTEMPT WAS MADE TO REMOVE THE GUIDE WIRE, SO IT IS UNKNOWN IF THE COILS ARE STILL ENTWINED WITH THE STENT. THERE WAS NO PART OF THE GUIDE WIRE LEFT IN THE ANATOMY. THE PROCEDURE WAS COMPLETED WITH A NEW GUIDE WIRE AND STENT DELIVERY SYSTEM. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7060287 ↗
• MalfunctionJul 6, 2017Detachment Of Device Component; Insufficient Device Problem Information

  REPORTEDLY, THE AFFILIATE WAS INSPECTING RETURN PRODUCTS AT THE LOCAL WAREHOUSE WHEN THEY NOTICED A 3.0X38MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS), A 3.0X15MM XIENCE XPEDITION SDS, AND TWO 014 BMW HYDRO GUIDE WIRE OUTSIDE THEIR CARTON. THE POUCHES WERE OPENED AND RE-CLOSED WITH A STAPLER. THE 3.0X15MM XIENCE XPEDITION SDS HAD NOTES ON THE LABEL STATING: STENT BROKEN INSIDE THE CATHETER. NO OTHER INFORMATION WAS PROVIDED FOR THE OTHER DEVICES. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS ON ONE OF THE .014 BMW HYDRO GUIDE WIRES OBSERVED THAT THE SHAPING RIBBON WAS SEPARATED AND THE TIP COILS WERE STRETCHED OUT AND SEPARATED. THE SEPARATED PIECES WERE NOT RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6690728 ↗