Angiographic Guide Wire 008632Recalls & reported problems
Medtronic, Inc. · WIRE ANG 008632 10PK .038 260 CTD SP GDE · 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 00643169857131), received between Feb 18, 2020 and Feb 18, 2020 — 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.
MalfunctionFeb 18, 2020Material Deformation; Material Deformation
AN ANGIOGRAPHIC WIRE (PLI 10) WAS USED DURING AN AORTIC STENOSIS CASE, DURING WHICH A STRAIGHT EXCHANGE WAS EMPLOYED THROUGH A NON MEDTRONIC PIGTAIL CATHETER. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN AS IT WAS A 0.038 STRAIGHT WIRE. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE WIRE UNRAVELED IN THE PATIENT. ALL OF THE DEVICE WAS REMOVED FROM THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY. A SECOND WIRE (PLI 30) FROM THE SAME LOT WAS OPENED AFTER THE CASE. THE WIRE DETACHED AT THE DISTAL END DURING INSPECTION, WHILE BEING PULLED ON. THE SECOND WIRE WAS NOT USED IN THE CASE AND WAS NOT IN CLINICAL USE. TWO ADDITIONAL UNOPENED WIRES LOT#: GFCV3917 WERE RECEIVED. PLI 20 ADDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9719231 ↗
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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