HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009665JRecalls & reported problems
Abbott Vascular Inc. · HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire J Tip Pak 300 cm · Class 2
All models of HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648118760), received between Jun 27, 2017 and Mar 8, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (2 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
Device problems
- Difficult to Remove2
- Break1
- Difficult to Advance1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 8, 2022Break; Difficult to Remove; Difficult to Advance; Break; Difficult to Remove; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE CIRCUMFLEX CORONARY ARTERY. THE BALANCE MIDDLE WEIGHT (BMW) GUIDE WIRE WAS ADVANCED TO THE TARGET LESION, BUT MET RESISTANCE WITH THE ANATOMY. WHEN THE GUIDE WIRE WAS BEING REMOVED, THERE WAS RESISTANCE WITH THE ANATOMY AND GUIDING CATHETER AND THE TIP BROKE BUT THE GUIDE WIRE REMAINED IN ONE PIECE AND WAS ABLE TO BE REMOVED AS ONE COMPLETE UNIT WITHOUT INTERVENTION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13695240 ↗InjuryJun 27, 2017Peeled/Delaminated; Difficult to Remove
IT WAS REPORTED A HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II 190CM J GUIDE WIRE WAS ADVANCED WITHOUT DIFFICULTY, THEN AN UNSPECIFIED BALLOON CATHETER WAS ADVANCED WITHOUT DIFFICULTY TO THE DISTAL TARGET LESION AND DILATATION WAS COMPLETED. WHEN RETRACTING THE BALLOON CATHETER AGAINST RESISTANCE OVER THE GUIDE WIRE, PEELING WAS NOTED ON AN UNSPECIFIED AREA OF THE DEVICE AFTER WITHDRAWAL. NO PART OF THE PEELED MATERIAL SEPARATED INSIDE OF PATIENT ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. THE PROCEDURE WAS CONSIDERED COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6670525 ↗
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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