HI-TORQUE PILOT 1010483-HJRecalls & reported problems
Abbott Vascular Inc. · HI-TORQUE PILOT 50 Guide Wire .014 J Tip3.0 cm x 300 cm · Class 2
All models of HI-TORQUE PILOT (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648073922), received between Oct 11, 2021 and Oct 11, 2021 — classified as 1 death.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Perforation of Vessels1
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathOct 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DIAGONAL CORONARY ARTERY. THE PILOT 50 GUIDE WIRE WAS USED AND DURING USE THE GUIDE WIRE CAUSED A PERFORATION TO THE VESSEL. A STENT WAS PLACED TO TREAT THE PERFORATION; HOWEVER, THE PERFORATION RESULTED IN A PERICARDIAL EFFUSION WHICH WAS DRAINED. THE PATIENT AT THIS TIME WAS TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER TREATMENT AND THE VESSEL WAS COILED TO TREAT THE PERFORATION. THE COILING OF THE PERFORATION CAUSED IN-STENT THROMBOSIS AND THE PATIENT HAD A STROKE. ULTIMATELY, THE PATIENT EXPIRED BUT IT IS NOT KNOWN WHEN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Perforation of Vessels; Pericardial Effusion
MAUDE report 12607956 ↗
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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