HI-TORQUE EXTRA S'PORT 22225MJRecalls & reported problems
Abbott Vascular Inc. · HI-TORQUE EXTRA S'PORT Guide Wire .014 J Tip 3.0 cm x 190 cm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648079597), received between Feb 22, 2019 and Feb 22, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).
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
- Device Damaged by Another Device1
- Entrapment of Device1
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 22, 2019Entrapment of Device; Material Separation; Device Damaged by Another Device; Entrapment of Device; Material Separation; Device Damaged by Another Device
IT WAS REPORTED THAT ON (B)(6) 2019, DURING A PLANNED STAGED PROCEDURE IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA), 2 XIENCE XPEDITION STENTS WERE SUCCESSFULLY IMPLANTED, USING AN XTRA S'PORT GUIDE WIRE. DURING REMOVAL OF THE GUIDE WIRE, RESISTANCE WAS NOTED WITH ONE OF THE IMPLANTED STENTS AND AN ATTEMPT WAS MADE TO REMOVE THE GUIDE WIRE BY USING A NON-ABBOTT MICRO CATHETER AND GUIDE EXTENSION. HOWEVER, THIS WAS NOT SUCCESSFUL AND FORCE WAS APPLIED. THE DISTAL STENT IN THE PROXIMAL RCA WAS SHORTENED AND THE GUIDE WIRE BROKE AND REMAINS IN THE VESSEL. TIMI FLOW WAS REDUCED TO 1. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO RE-OPEN THE VESSEL, BUT TIMI FLOW REMAINED AT 1. NO ADDITIONAL INTERVENTION WAS PERFORMED, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT WAS NOTED TO BE RECOVERING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 8364542 ↗
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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