HI-TORQUE BALANCE MIDDLEWEIGHT 1001782-HCRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648025990), received between Nov 17, 2016 and Jan 27, 2024 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 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.

• 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 18592767 ↗
• MalfunctionDec 21, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT STATED: THE SEPARATION OF THE GUIDE WIRE OCCURRED DURING REMOVAL OF THE BALLOON WHICH WAS OVER THE GUIDE WIRE. THE SEPARATED PORTION REMAINED IN THE BALLOON CATHETER AND WAS SIMPLY REMOVED WITH THE BALLOON CATHETER. NO INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18379030 ↗
• MalfunctionFeb 23, 2022Difficult to Remove; Stretched; Material Twisted/Bent; Difficult to Remove; Stretched; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY. POST STENTING OF THE TARGET LESION AND ONCE THE PROCEDURE WAS ALREADY COMPLETED, AS THE DRAGONFLY OPSTAR CATHETER WAS ATTEMPTED TO BE REMOVED, IT BECAME STUCK ON THE BALANCE MIDDLEWEIGHT GUIDE WIRE. BOTH UNITS WERE REMOVED TOGETHER FROM THE ANATOMY WITHOUT ISSUE. THE DISTAL END OF THE GUIDE WIRE WAS NOTED TO BE TWISTED AND STRETCHED. THE TIP OF THE DRAGONFLY CATHETER WAS NOTED TO BE CRUSHED/COLLAPSED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS OF THE DRAGONFLY CATHETER REVEALED THAT THE GUIDE WIRE EXIT PORT WAS TORN DISTALLY FOR A LENGTH OF 5MM. THE DISTAL TIP WAS TORN AND STRETCHED AND A PORTION OF THE DISTAL TIP WAS SEPARATED AND NOT RETURNED. ADDITIONAL REPORTED INFORMATION INDICATES THAT THE TIP WAS INTACT WHEN THE DRAGONFLY CATHETER WAS PULLED BACK INTO THE GUIDE CATHETER AND IT WAS CONFIRMED THAT NO PORTION OF THE DEVICE REMAINED IN THE PATIENT ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13586735 ↗
• InjuryAug 5, 2021Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT POSTERIOR TIBIAL ARTERY. VESSEL ACCESS WAS VIA THE LEFT COMMON FEMORAL ARTERY. AN ANGLED NON-ABBOTT GUIDE WIRE WAS ADVANCED; HOWEVER, THE DEVICE WAS UNABLE TO CROSS. THEREFORE, RETROGRADE ACCESS WAS MADE VIA THE PEDAL ARTERY. THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED; HOWEVER, RESISTANCE WAS NOTED DUE TO THE PATIENT ANATOMY. THE GUIDE WIRE WAS NOTED TO SEPARATE INTO TWO SEGMENTS, BUT WAS ABLE TO BE EASILY REMOVED FROM THE ANATOMY. NO DIFFICULTY WAS NOTED DURING REMOVAL. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12282337 ↗
• InjuryMar 3, 2021Off-Label Use; Difficult to Remove; Material Separation; Off-Label Use; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT DURING A SHOCKWAVE PROCEDURE IN THE RIGHT COMMON FEMORAL ARTERY (CFA), TWO NON-ABBOTT DEVICES BECAME STUCK WITH EACH OTHER WHILE ADVANCING OVER A 3CM 014 BALANCED MIDDLE WEIGHT (BMW) HYDRO GUIDE WIRE (GW). THE DEVICES WERE REMOVED AGAINST RESISTANCE, BUT THE BMW GUIDE WIRE REMAINED IN PLACE AND A NEW, NON-ABBOTT DEVICE WAS ADVANCED OVER THE WIRE. DURING REMOVAL OF THE NON-ABBOTT DEVICE, APPROXIMATELY 15CM OF THE DISTAL BMW GUIDE WIRE SEPARATED AND REMAINED IN THE ANATOMY. A SNARE WAS USED TO SUCCESSFULLY REMOVE THE SEPARATED PORTION OF THE BMW. 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 11406631 ↗
• InjuryAug 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT FEMORAL VEIN. THE BALANCE MIDDLE WEIGHT HYDRO GUIDE WIRE WAS ADVANCED WITHOUT ISSUE TO THE LESION. IT WAS DECIDED TO PERFORM A SHEATH EXCHANGE AS THE PHYSICIAN WAS UNSATISFIED WITH THE CURRENT SHEATH. WHILE PERFORMING THE SHEATH EXCHANGE, THE DISTAL TIP OF THE GUIDE WIRE BROKE IN TWO PIECES. A SNARE DEVICE WAS USED TO RETRIEVE THE FREE-FLOATING TIP. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10440521 ↗
• InjuryJun 12, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. THE BALANCE MIDDLEWEIGHT HYDRO GUIDE WIRE TIP SEPARATED DURING REMOVAL. THERE WAS NO RESISTANCE NOTED DURING REMOVAL. THE SEPARATED TIP WAS EMBEDDED IN THE VESSEL. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 10150774 ↗
• InjuryJun 3, 2020Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND MILDLY TORTUOUS LESION IN THE POPLITEAL ARTERY. AN UNSPECIFIED BALLOON WAS UNABLE TO ADVANCE OVER THE 014 BALANCED MIDDLE WEIGHT (BMW) GUIDE WIRE. IT WAS NOTED THAT THE GUIDE WIRE SEPARATED AND HALF OF THE WIRE REMAINED IN THE PATIENT ANATOMY. AN ATTEMPT TO SNARE THE SEPARATED GUIDE WIRE PIECE FROM THE ANATOMY WAS MADE; HOWEVER, IT WAS UNSUCCESSFUL. THE PATIENT WAS SENT TO SURGERY AND THE WIRE WAS SUCCESSFULLY REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10116773 ↗
• InjuryApr 13, 2020Difficult to Remove; Material Separation; Device Damaged by Another Device; Difficult to Advance; Difficult to Remove; Material Separation; Device Damaged by Another Device; Difficult to Advance

  IT WAS REPORTED THAT THIS WAS A VERY COMPLEX CASE IN A HEAVILY CALCIFIED AND HEAVILY TORTUOUS RIGHT CORONARY ARTERY (RCA) WITH 90% STENOSIS WHICH REQUIRED MULTIPLE DEVICES, MULTIPLE PREDILATATIONS, AND ATHERECTOMY. FOUR OVERLAPPING XIENCE SIERRA STENTS WERE IMPLANTED ALONG THE LENGTH OF THE RCA WITH THE FOURTH STENT EXTENDING INTO THE OSTIUM. THERE WAS GOOD FLOW AND GOOD HEMODYNAMICS. IVUS (INTRAVASCULAR ULTRASOUND) WAS PERFORMED AND SHOWED NO DISSECTIONS. POST-DILATATION WAS PERFORMED ALONG THE ENTIRE LENGTH OF THE FOUR STENTS WITH A 3.0X30 NONCOMPLIANT BALLOON DILATATION CATHETER (BDC) AT 20 TO 24 ATMOSPHERES. DURING REMOVAL OF THE BDC IT WAS DIFFICULT TO REMOVE FROM THE NON-ABBOTT GUIDE WIRE, SO BOTH WERE REMOVED AS A UNIT. THE BMW (BALANCE MIDDLE WEIGHT) GUIDE WIRE WAS ADVANCED, BUT BECAME CAUGHT UNDER A STENT STRUT IN THE OSTIAL RCA. WHEN THE WIRE WAS RETRACTED, APPROXIMATELY 1 TO 2 MM OF THE TIP SEPARATED FROM THE GUIDE WIRE. A SNARE WAS UNABLE TO BE USED BECAUSE ADDITIONAL GUIDE WIRES WERE UNABLE TO ADVANCE THROUGH THE STENT STRUTS. THE PROLONGED ATTEMPTS TO REMOVE THE WIRE REFERENCED IN THE ATTACHED 3500 MW WERE REFERRING TO THE ATTEMPTS TO ADVANCE ANOTHER GUIDE WIRE THROUG

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9953234 ↗
• InjuryApr 6, 2020Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). THE RCA WAS INITIALLY WIRED WITH A NON-ABBOTT GUIDE WIRE AND PRE-DILATED WITH AN NON-ABBOTT BALLOON. WHEN REMOVING THE BALLOON, THE GUIDE WIRE FELT STICKY. THE GUIDE WIRE WAS REMOVED AND A BMW GUIDE WIRE WAS USED. REPORTEDLY, RESISTANCE WITH THE ANATOMY WAS NOTED DURING ADVANCEMENT. THE TIP OF THE BMW GUIDE WIRE BROKE OFF. THE TIP WAS SNARED, DRAGGED TO THE OSTIUM OF THE VESSEL AND STENTED OVER, HOWEVER; IT WAS UNABLE TO BE POST DILATED. PATIENT DID FINE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9928672 ↗
• InjuryNov 20, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY TORTUOUS AND CONCENTRIC LESION IN THE MID ILIAC ARTERY. A 014 BMW HYDRO GUIDE WIRE WAS ADVANCED TO THE LESION AND AN INTRAVASCULAR ULTRASOUND CATHETER WAS ADVANCED OVER THE GUIDE WIRE WITHOUT RESISTANCE; HOWEVER, THE TIP OF THE GUIDE WIRE SEPARATED. A SNARE WAS USED TO REMOVE THE SEPARATED TIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 014 BMW HYDRO GUIDE WIRE. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8091166 ↗
• MalfunctionOct 22, 2018Peeled/Delaminated; Product Quality Problem; Failure to Advance; Peeled/Delaminated; Product Quality Problem; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TORTUOUS AND CALCIFIED LESION IN THE LEFT CIRCUMFLEX (CX) CORONARY ARTERY WITH 80% STENOSIS. WHEN ATTEMPTING TO ADVANCE THE BALANCE MIDDLEWEIGHT (BMW) HYDRO GUIDE WIRE, THE GUIDE WIRE WAS NOTED TO HAVE A GRITTY FEELING AND DID NOT FEEL THE WAY A BMW GUIDE WIRE TYPICALLY FEELS. IT FELT LIKE THE COATING HAD BEEN STRIPPED. THE GUIDE WIRE DID NOT ADVANCE TO THE LESION AND WAS REMOVED FROM THE PATIENT. IT WAS CONFIRMED THAT NONE OF THE GUIDE WIRE COATING REMAINED IN THE PATIENT ANATOMY. AN UNSPECIFIED GUIDE WIRE WAS USED TO CONTINUE THE PROCEDURE; HOWEVER, THE PROCEDURE WAS ULTIMATELY ABORTED AS NOTHING WAS ABLE TO ADVANCE IN THE PATIENT DUE TO THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7992085 ↗
• InjuryNov 17, 2016Detachment Of Device Component; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT A LESION IN THE RIGHT COMMON ILIAC ARTERY, A 014 BALANCE MIDDLEWEIGHT (BMW) HYDRO 3CM GUIDE WIRE WAS ADVANCED VIA RIGHT GROIN ACCESS PAST THE LESION WITHOUT ISSUE. A NON-ABBOTT INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS ADVANCED OVER THE BMW TO THE LESION WITHOUT ISSUE AND IMAGES WERE OBTAINED. WHEN RETRACTING THE IVUS BACK OVER THE BMW, RESISTANCE WAS FELT. FORCE WAS APPLIED AGAINST RESISTANCE TO COMPLETELY RETRACT THE IVUS OFF OF THE BMW. IT WAS THEN NOTED THAT THE BMW GUIDE WIRE HAD SEPARATED IN PATIENT ANATOMY; WHILE THE CORE WAS OUTSIDE OF THE ANATOMY, THREE TIP PIECES WERE FOUND INSIDE OF THE ILIAC VESSEL AND A PERFORATION WAS ALSO NOTED; THE EXACT CAUSE OF THE PERFORATION IS REPORTEDLY UNKNOWN. ANOTHER BMW GUIDE WIRE WAS ADVANCED WITHOUT ISSUE THEN BALLOON TAMPONADE OF THE PERFORATION WAS ATTEMPTED WITH AN UNSPECIFIED BALLOON, BUT THE PERFORATION DID NOT SEAL. A NON-ABBOTT STENT GRAFT WAS THEN DEPLOYED AND SUCCESSFULLY SEALED THE PERFORATION. TWO TIP PIECES WERE ABLE TO BE SNARED SUCCESSFULLY. THE FINAL TIP PIECE (3RD ) WAS SUCCESSFULLY RETRIEVED VIA A SMALL CUT DOWN OF THE ILIAC ARTERY AND THE LESION WAS SUCCESSFULLY TREA

  Patient problems: Perforation

  MAUDE report 6111640 ↗