HI-TORQUE WIGGLE 22399M-W30Recalls & reported problems
Abbott Vascular Inc. · HI-TORQUE WIGGLE Guide Wire .014 Straight Tip 30 cm x 300 cm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648080487), received between Apr 24, 2017 and May 30, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Material Separation1
Patient problems
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 30, 2023Material Separation; Material Separation
IT WAS REPORTED THAT ON REMOVAL OF THE WIGGLE GUIDEWIRE, THE DISTAL TIP WAS NOTED TO HAVE SEPARATED. THERE WAS REPORTEDLY NO RESISTANCE REPORTED DURING ADVANCEMENT OR REMOVAL OF THE WIRE. THE SEPARATED PORTION REMAINED IN THE CIRCUMFLEX CORONARY ARTERY AND NO ATTEMPT WAS MADE TO RETRIEVE THE TIP. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AS A RESULT OF THE TIP BEING LEFT IN THE DISTAL CIRCUMFLEX. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 17020853 ↗MalfunctionApr 24, 2017Difficult to Remove
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUDED LESION IN THE CIRCUMFLEX ARTERY. A 2.5X15MM XIENCE RX STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY; HOWEVER, IT WAS DECIDED THAT ANOTHER STENT WAS NEEDED DISTALLY DUE TO THE LOW BLOOD FLOW. A 2.5X23MM XIENCE ALPINE RX STENT WAS DEPLOYED AT 12 ATMOSPHERES DISTALLY; HOWEVER, THE DELIVERY SYSTEM WAS PULLED BACK A LITTLE BIT TO BALLOON THE AREA WHERE BOTH STENTS OVER-LAPPED WHEN THE BALLOON RUPTURED. RESISTANCE WITH THE GUIDE WIRE WAS FELT WHEN REMOVING THE DELIVERY SYSTEM. BOTH THE DELIVERY SYSTEM AND GUIDE WIRE WERE REMOVED TOGETHER. IT WAS FURTHER REPORTED THAT THE 2.5X23MM XIENCE ALPINE DELIVERY SYSTEM WAS NOT PREPPED PRIOR TO USE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION: THE RETURN DEVICE ANALYSIS REVEALED THAT THE XIENCE ALPINE STENT DELIVERY SYSTEM WAS RETURNED FROZEN ON AN ABBOTT .014 WIGGLE GUIDE WIRE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6516653 ↗
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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