HI-TORQUE PILOT 1010482-HJRecalls & reported problems
Abbott Vascular Inc. · HI-TORQUE PILOT 200 Guide Wire .014 J Tip 3.0 cm x 190 cm · Class 2
All models of HI-TORQUE PILOT (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648073908), received between Sep 20, 2017 and Aug 18, 2026 — classified as 1 injury, 3 malfunctions.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove2
- Peeled/Delaminated2
- Detachment Of Device Component1
- Difficult to Advance1
- Material Separation1
- Physical Resistance1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50303401 ↗MalfunctionAug 18, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50303394 ↗MalfunctionMay 16, 2023Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 014 HI-TORQUE PILOT 200 GUIDEWIRE (GW) WAS ATTEMPTED TO TO ADVANCED TO THE TARGET LESION WITH A GUIDE EXTENSION CATHETER; HOWEVER, AFTER AN HOUR OF MANIPULATING THE GW, THE TIP BROKE INSIDE THE GUIDE CATHETER. THEREFORE, THE GW, GUIDE EXTENSION CATHETER AND GUIDE CATHETER HAD TO BE REMOVED AS A SINGLE UNIT. AFTER REMOVAL THE SEPARATED PORTION OF THE GW WAS FOUND INSIDE THE GUIDE CATHETER. THEN, THE PROCEDURE WAS CONTINUED USING ANOTHER HI-TORQUE PILOT GW; HOWEVER, THE GW WAS UNABLE TO CROSS THE LESION DUE THE ANATOMY. THEREFORE, THE GW WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. THE PHYSICIAN DECIDED TO END THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16939753 ↗InjurySep 20, 2017Detachment Of Device Component; Difficult to Remove; Physical Resistance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) MID RIGHT CORONARY ARTERY (RCA) AND A HEAVILY CALCIFIED NARROW LESION IN THE PROXIMAL RCA. A HI-TORQUE PILOT 200 GUIDE WIRE (GW) WAS ADVANCED PAST THE PROXIMAL RCA WITHOUT RESISTANCE, BUT WHILE CROSSING THE MID RCA RESISTANCE WAS FELT WITH NO FORCE APPLIED. AFTER CROSSING THE CTO, AN UNSPECIFIED BALLOON WAS ADVANCED AND ANGIOPLASTY WAS PERFORMED. WITH THE BALLOON IN PLACE, DURING ATTEMPTED GUIDE WIRE EXCHANGE, THE PILOT GW WAS PULLED BACK, RESISTANCE WAS FELT AGAINST THE CTO, AND, THOUGH NO FORCE WAS APPLIED, THE TIP SEPARATED IN THE VESSEL. THE TIP WAS SUCCESSFULLY SNARED. THE PROCEDURE WAS ABORTED WITH PLANS TO TREAT THE TARGET LESION AT ANOTHER TIME. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6881182 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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