Magic Torque™ DLVR M001465300Recalls & reported problems
Boston Scientific Corporation · Glidex™ Coated Hydrophilic Guidewire · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729982890), received between Sep 30, 2019 and Oct 22, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Entrapment of 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 16, 2026.
Most reported problems
Device problems
- Entrapment of Device1
- Material Integrity Problem1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2019Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT GUIDEWIRE COATING FRAY ENCOUNTERED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON TORTUOUS SUPERFICIAL FEMORAL ARTERY. A GW/.035/315 (BX/3) MAGIC TORQUE DLVR GUIDEWIRE WAS USED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE BACK END OF THE WIRE COATING WAS FRAYED UPON REMOVING THE ANGIOJET CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9220293 ↗MalfunctionSep 30, 2019Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT GUIDEWIRE AND CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A .035 MAGIC TORQUE GUIDEWIRE WAS USED WITH A 7X100, 130CM ELUVIA SELF-EXPANDING STENT. DURING THE PROCEDURE THE GUIDEWIRE BECAME STUCK WITHIN THE STENT DELIVERY SYSTEM AND COULD NOT BE REMOVED. THE MAGIC TORQUE GUIDEWIRE AND THE ELUVIA STENT DELIVERY SYSTEM WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS THEN COMPLETED USING A NEW GUIDEWIRE AND A 7X40MM ELUVIA STENT. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9136354 ↗
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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