SPARTACORE 1005205Recalls & reported problems
Abbott Vascular Inc. · HI-TORQUE SPARTACORE 14 Peripheral Guide Wire .014 10 cm x 190 cm · Class 2
All models of SPARTACORE (4)
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 08717648014055), received between Mar 1, 2018 and Mar 1, 2018 — 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
- Difficult to Remove1
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.
InjuryMar 1, 2018Detachment Of Device Component; Difficult to Remove
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN OCCLUSIVE LESION LOCATED IN THE DISTAL PERONEAL ARTERY. DURING DILATATION OF THE RIGHT LEG ARTERY, THE DISTAL TIP OF THE HIGH-TORQUE SPARTACORE PERIPHERAL GUIDE WIRE SEPARATED IN THE ATHEROMA PLAQUE DURING REMOVAL. THE TIP REMAINS LOCATED IN THE RIGHT PERONEAL ARTERY. AN ATTEMPT WAS MADE TO REMOVE THE TIP BUT IT COULD NOT BE EXTRACTED FROM THE ATHEROMA PLAQUE AND REMAINS IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 7308330 ↗
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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