HI-TORQUE BALANCE HEAVYWEIGHT 1000462HJRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648015496), received between Mar 17, 2017 and Oct 2, 2025 — classified as 6 injuries, 4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2025Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT CIRCUMFLEX (RCX) ARTERY. A NON-ABBOTT MICROCATHETER DID NOT PASS THE LESION THEREFORE THE BHW GUIDE WIRE WAS ADVANCED AND ABLE TO CROSS THE DISTAL RCX. THE MICROCATHTER WAS ATTEMPTED TO BE ADVANCED OVER THE BHW WITH TURNING MOVEMENTS OF THE MICROCATHTER. DURING THIS TRY THE RADIOPAQUE TIP OF THE GUIDE WIRE BROKE INTO TWO PARTS. THE PROXIMAL END OF THE GUIDE WIRE WAS ABLE TO BE RETRACTED; HOWEVER THE TIP OF THE GUIDE WIRE WAS IN THE DISTAL PART OF THE RCX AND WAS NOT REMOVED. THE PATIENT REQUIRED AN EXTENDED HOSPITAL STAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23198549 ↗
• InjuryJun 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THE BHW HYDRO GUIDE WIRE (GW) WAS PLACED IN A SAPHENOUS VEIN. THE PROCEDURE CONTINUED TO ADDRESS OTHER LESIONS; HOWEVER UPON COMPLETION, WHEN ATTEMPTING TO REMOVE THE BHW, IT WAS NOTICED THAT PART OF THE GW WAS OUTSIDE THE CATHETER WHILE ANOTHER PART PROTRUDED THROUGH THE CATHETER INTO THE SAPHENOUS VEIN. THE GUIDEWIRE HAD SEPARATED INTO TWO PIECES. SINCE THE DISTAL PART REMAINED INSIDE THE CATHETER FOR ABOUT 5 CM, IT WAS CAPTURED WITH A BALLOON AND THE ENTIRE ASSEMBLY (CATHETER, PART OF THE GUIDEWIRE, AND BALLOON) WAS REMOVED. 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 22227095 ↗
• MalfunctionJun 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THE BHW HYDRO GUIDE WIRE (GW) WAS SET ASIDE TO SOAK PRIOR TO USE. WHEN IT WAS PICKED UP AGAIN IT WAS NOTED THE GUIDE WIRE WAS SEPARATED APPROXIMATELY 39CM FROM THE DISTAL TIP. 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 22151277 ↗
• MalfunctionMay 29, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNKNOWN VESSEL. A 190CM HI-TORQUE 014 BHW HEAVYWEIGHT GUIDEWIRE (GW) WAS INSERTED INTO THE ANATOMY; HOWEVER, A FLAW ON THE RADIO MARKER WAS NOTED [POTENTIAL VISIBILITY ISSUES]. THEREFORE, THE DEVICE COULD NOT BE USED. THE PROCEDURE WAS CONTINUED WITH THE USE OF A NON-ABBOTT DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106252 ↗
• MalfunctionMar 7, 2024Material Separation; Material Separation

  SUBSEQUENTLY, IT WAS NOTED THAT THAT NO PIECE OF THE GUIDE WIRE LEFT IN THE ANATOMY AND PER DEVICE RETURN IT WAS NOTED THAT THE ENTIRE LENGTH OF THE GUIDE WIRE WAS RETURNED; HOWEVER, SEPARATED FROM THE DISTAL CORE AND SHAPING RIBBON FROM THE SOLDER TIP. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862434 ↗
• InjuryFeb 8, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE HI-TORQUE BALANCE HEAVYWEIGHT HYDRO 014 GUIDE WIRE WAS NOTED TO HAVE CRUMBLING COATING (TEFLON COATING) DURING AN UNSPECIFIED PROCEDURE. IT CANNOT BE CONFIRMED THAT NO FOREIGN MATERIAL REMAINS IN THE ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18672804 ↗
• InjuryNov 8, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN RIGHT ILIAC ARTERY. DURING THE PROCEDURE, THE DISTAL PORTION OF THE HI-TORQUE 014 BHW HYDRO 190CM GUIDEWIRE (GW) BROKE IN THE CHEST / ABDOMEN OF THE PATIENT AND WAS SUCCESSFULLY SNARED AND RETRIEVED. THE PATIENT WAS ADMITTED FOR ADDITIONAL OBSERVATION. THERE WAS NO ADVERSE PATIENT SEQUELA. USER FACILITY MEDWATCH (B)(4) REPORT RECEIVED THAT STATES "WIRE BREAKAGE IN THE CHEST AND ABDOMEN RETRIEVED USING FOREIGN BODY RETRIEVAL DEVICE. FINALLY ATTEMPT TO RECANALIZATION OF THE SUPERIOR VENA CAVA WAS UNSUCCESSFUL. ATTEMPT TO RECANALIZED THE RIGHT SUBCLAVIAN VEIN TO THESE SUPERIOR VENA CAVA WAS UNSUCCESSFUL. RIGHT UPPER EXTREMITY MIDLINE PLACEMENT 20 CM LENGTH WITH THE TIP IN THE SUPERIOR VENA CAVA." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15757208 ↗
• MalfunctionMar 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE AORTIC VALVE. DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION, TWO GUIDE WIRES (BALANCE MIDDLEWEIGHT AND BALANCE HEAVYWEIGHT) WERE NOTED AS BROKEN IN TWO PIECES. BOTH DEVICES WERE SIMPLY REMOVED. TWO OTHER UNSPECIFIED DEVICES WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9780778 ↗
• InjuryNov 6, 2019Entrapment of Device; Material Separation; Stretched; Entrapment of Device; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY. A HI-TORQUE BALANCE HEAVYWEIGHT HYDRO GUIDE WIRE WAS ABLE TO BE ADVANCED PASSED A PREVIOUSLY IMPLANTED STENT FROM 8 YEARS AGO, HOWEVER, WHEN THE GUIDE WIRE WAS PULLED BACK FOR REMOVAL IT FELT STUCK (BELIEVED TO BE STUCK WITHIN STENT STRUTS). THE GUIDE WIRE WAS THEN PULLED BACK ONCE MORE AND IT BROKE IN TWO PIECES AND WAS NOTED AS STRETCHED. THE SEPARATED GUIDE WIRE PIECE WAS RETRIEVED VIA SNARE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9286574 ↗
• InjuryMar 17, 2017Detachment Of Device Component; Difficult To Position; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MILDLY TORTUOUS CORONARY ARTERY. A BALANCE HEAVYWEIGHT (BHW) HYDRO GUIDE WIRE WAS SELECTED FOR THE PROCEDURE. THE BHW HYDRO GUIDE WIRE WAS ADVANCED TOWARD THE LESION; MET RESISTANCE NEAR THE SHOULDER AND WOULD NOT ADVANCE ANY FURTHER. THE PHYSICIAN THEN TRIED TO ADVANCE AN UNSPECIFIED CATHETER OVER THE GUIDE WIRE AND ALSO MET RESISTANCE. THE CATHETER AND THE BHW GUIDE WIRE WERE REMOVED FROM THE ANATOMY AS ONE UNIT. ONCE THE GUIDE WIRE WAS REMOVED FROM THE ANATOMY, IT WAS DISCOVERED THAT THE TIP OF THE GUIDE WIRE HAD SEPARATED AND WAS STILL IN THE ANATOMY. A SNARE WAS USED TO RETRIEVE THE SEPARATED TIP FROM THE ANATOMY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN COMMENTED THAT THE TIP SEPARATION WAS DUE TO THE PATIENT'S ANATOMY AND THE RADIAL ACCESS SITE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6414775 ↗