HI-TORQUE POWERTURN 1044593Recalls & reported problems
Abbott Vascular Inc. · HI-TORQUE POWERTURN FLEX Guide Wire w/Hydrophilic Coating .014" Straight Tip 300 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 08717648173950), received between Feb 18, 2019 and Feb 18, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation1
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.
InjuryFeb 18, 2019Material Separation; Material Separation
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED OBTUSE MARGINAL BRANCH DURING A JUMP GRAFT PROCEDURE. A 300 CM POWERTURN FLEX GUIDE WIRE WAS ADVANCED TOWARDS THE LESION AND DID NOT MEET ANY RESISTANCE DURING ADVANCEMENT OR REMOVAL. APPROXIMATELY FIVE UNSPECIFIED STENTS WERE IMPLANTED IN THE LESION, AND UNSPECIFIED BALLOON CATHETERS WERE USED. HOWEVER, DURING THE FOURTH OR FIFTH STENT DEPLOYMENT, IT WAS NOTED UNDER FLUOROSCOPY THAT THE UNSPECIFIED STENT DELIVERY SYSTEM (SDS) WAS IN THE LEFT ANTERIOR DESCENDING ARTERY INSTEAD OF THE TARGET LESION. THEREFORE, BOTH THE SDS AND GUIDE WIRE WERE PULLED BACK; HOWEVER, THE TIP OF THE GUIDE WIRE SEPARATED IN THE OBTUSE MARGINAL BRANCH. THERE WERE MULTIPLE FAILED ATTEMPTS TO SNARE THE TIP AND BALLOON INFLATION WAS ALSO PERFORMED. A NON-ABBOTT GUIDE WIRE WAS THEN USED ALONG WITH THE POWERTURN GUIDE WIRE. A 2.75 X 8 MM UNSPECIFIED XIENCE STENT WAS ADVANCED OVER THE NON-ABBOTT GUIDE WIRE AND DEPLOYED TO EMBED THE TIP OF THE POWERTURN GUIDE WIRE IN THE OBTUSE MARGINAL BRANCH. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Vessel Or Plaque, Device Embedded In
MAUDE report 8347521 ↗
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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