Cross-it 1003309HRecalls & reported problems
Abbott Vascular Inc. · HI-TORQUE CROSS-IT 100XT Guide Wire w/Hydrocoat Hydrophilic Coating .014 Straight Tip 3.0 cm x 190 cm · Class 2
Data updated Oct 16, 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 08717648034800), received between Sep 21, 2017 and Sep 21, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment Of Device Component” (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 16, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
- Device Operates Differently Than Expected1
- Failure to Advance1
- Improper or Incorrect Procedure or Method1
Patient problems
- Vessel Or Plaque, Device Embedded In1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2017Detachment Of Device Component; Improper or Incorrect Procedure or Method; Failure to Advance; Device Operates Differently Than Expected
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION IN THE HEAVILY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE HT CROSS-IT 100 XT GUIDE WIRE WAS ADVANCED TO THE LESION, BUT MET RESISTANCE AND WOULD NOT CROSS. THE PHYSICIAN TRIED TORQUEING THE WIRE, BUT THE TIP GOT STUCK IN THE PLAQUE AND FORMED A LOOP. WHEN THE GUIDE WIRE WAS REMOVED FROM THE ANATOMY, THE LOOP THAT HAD FORMED BROKE OFF. IT WAS DETERMINED THAT THE SEPARATED TIP WAS IN THE SUBINTIMAL OF THE LAD; THEREFORE, NO ATTEMPT WAS MADE TO REMOVE THE TIP FROM THE ANATOMY. AN HT CROSS-IT 200 XT GUIDE WIRE WAS THEN SELECTED FOR THE PROCEDURE, BUT IT MET RESISTANCE AND WOULD NOT CROSS. THE GUIDE WIRE WAS REMOVED FROM THE ANATOMY AND THE PROCEDURE WAS STOPPED AT THAT POINT. THE PATIENT DID NOT COMPLAIN OF ANY CHEST PAIN OR DISCOMFORT FOLLOWING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Vessel Or Plaque, Device Embedded In
MAUDE report 6884262 ↗
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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