Angiographic Guide Wire 007042 (UDI 00763000577254)Recalls & reported problems
Medtronic, Inc. · WIRE ANG 007042 10PK 9266S.035 145 3MMJ · Class 2
All models of Angiographic Guide Wire (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000577254), received between Feb 22, 2023 and Mar 2, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (3 reports).
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 Integrity Problem3
- Peeled/Delaminated3
Patient problems
- Device Embedded In Tissue or Plaque3
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2023Peeled/Delaminated; Material Integrity Problem; Peeled/Delaminated; Material Integrity Problem
AN ATTEMPT WAS MADE TO USE ONE ANGIOGRAPHIC GUIDEWIRE IN A PROCEDURE. IT WAS REPORTED THAT THE COATING ON THE J TIP OF THE GUIDEWIRE WAS RUBBING OFF. SEVEN UNUSED ANGIOGRAPHIC GUIDEWIRES WITH THE SAME LOT WERE RETURNED TO MEDTRONIC. THE ANGIOGRAPHIC GUIDEWIRES ARE STORED IN AN AIRCONDITIONED ROOM, THE SAME ENVIRONMENT AS STERILE STOCK. NO PATIENT INJURY REPORTED.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 16467574 ↗MalfunctionFeb 22, 2023Peeled/Delaminated; Material Integrity Problem; Peeled/Delaminated; Material Integrity Problem
AN ATTEMPT WAS MADE TO USE TWO ANGIOGRAPHIC GUIDEWIRES. A 6FR JL4 GUIDE CATHETER WAS IN USE. THE GUIDEWIRES WERE USED WITHIN A DIAGNOSTIC CATHETER VIA FEMORAL ACCESS. THE GUIDEWIRES WERE MOISTENED PRIOR TO USE, NOT WIPED. IT WAS REPORTED THAT THE COATING ON THE J TIP OF THE GUIDEWIRES WAS RUBBING OFF. RESISTANCE FELT WRONG AND IT WAS DECIDED TO PULL EVERYTHING OUT. ONCE REMOVED IT WAS NOTED THAT THE COATING HAD GATHERED. THE COATING CAME OFF DURING THE PROCEDURE AND BLOCKED THE CATHETER. THE ANGIOGRAPHIC GUIDEWIRES ARE STORED IN AN AIRCONDITIONED ROOM, THE SAME ENVIRONMENT AS STERILE STOCK. NO PATIENT INJURY WAS REPORTED.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 16415634 ↗MalfunctionFeb 22, 2023Peeled/Delaminated; Material Integrity Problem; Peeled/Delaminated; Material Integrity Problem
AN ATTEMPT WAS MADE TO USE TWO ANGIOGRAPHIC GUIDEWIRES. A 6FR JL4 GUIDE CATHETER WAS IN USE. THE GUIDEWIRES WERE USED WITHIN A DIAGNOSTIC CATHETER VIA FEMORAL ACCESS. THE GUIDEWIRES WERE MOISTENED PRIOR TO USE, NOT WIPED. IT WAS REPORTED THAT THE COATING ON THE J TIP OF THE GUIDEWIRES WAS RUBBING OFF. RESISTANCE FELT WRONG AND IT WAS DECIDED TO PULL EVERYTHING OUT. ONCE REMOVED IT WAS NOTED THAT THE COATING HAD GATHERED. THE COATING CAME OFF DURING THE PROCEDURE AND BLOCKED THE CATHETER. THE ANGIOGRAPHIC GUIDEWIRES ARE STORED IN AN AIRCONDITIONED ROOM, THE SAME ENVIRONMENT AS STERILE STOCK. NO PATIENT INJURY WAS REPORTED.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 16415631 ↗
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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