Angiographic Guide Wire 010388Recalls & reported problems
Medtronic, Inc. · WIRE ANG 010388 10PK .025X145CM 3MMJPCS · Class 2
All models of Angiographic Guide Wire (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169857278), received between Apr 5, 2019 and Apr 5, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 5, 2019Material Deformation; Material Deformation
AN ANGIOGRAPHIC WIRE WAS USED DURING A PROCEDURE. THE LESION WAS LOCATED IN THE CORONARY SINUS OSTIUM (DURING A CRT IMPLANT). NO DAMAGE NOTED TO PACKAGING. NO ISSUES REMOVING THE DEVICE FROM THE PACKAGING AS PER IFU. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN. IT WAS REPORTED THAT DAMAGE WAS NOTED TO THE DEVICE AFTER REMOVAL FROM THE PATIENT. THE PHYSICIAN USED THE ANGIOGRAPHIC WIRE INSIDE AN ATTAIN COMMAND CATHETER TO ACCESS THE CORONARY SINUS . AFTER TRYING TO PASS THE SUPERIOR VENA CAVA (ATRIAL AND RV LEAD WERE PREVIOUSLY IMPLANTED - DURING THE SAME PROCEDURE) THE PHYSICIAN NOTED THAT THE GUIDE WIRE WAS KINKED. THE PROCEDURE WAS COMPLETED USING ANOTHER 0.025" WIRE. NO PATIENT INJURY REPORTED. ANALYSIS REVEALED COILS SEPARATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8486647 ↗
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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