Reuter G00763Recalls & reported problems
Cook Incorporated · Reuter Tip Deflecting Wire Guide · Class 2
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 00827002007635), received between Nov 17, 2017 and May 31, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment Of Device Component” (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
- Detachment Of Device Component1
- Material Separation1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 31, 2023Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17030959 ↗MalfunctionFeb 12, 2019Material Separation; Material Separation
IT WAS REPORTED, PRIOR TO PATIENT CONTACT, A PHYSICIAN FOUND THE REUTER TIP DEFLECTING WIRE GUIDE HAD SEPARATED 5CM FROM THE HUB. THE SEPARATION WAS NOTED AFTER ANCHORING THE SIDE-ARM FITTING TO THE HANDLE, PRIOR TO ANY PATIENT CONTACT. THE DEVICE WAS NOT USED. ANOTHER MANUFACTURER'S DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
Patient problems: No Patient Involvement
MAUDE report 8332437 ↗MalfunctionNov 17, 2017Detachment Of Device Component; Detachment Of Device Component
THE TDW-25-100-5 WAS ADVANCED FROM THE RADIAL ARTERY DURING THE PROCEDURE. THE METALLIC PART OF THE THE PROXIMAL END OF THE WIRE GUIDE SEPARATED FROM THE DEFLECTOR HANDLE WHILE BEING USED AND THE WIRE GUIDE BECAME IMPOSSIBLE TO MANIPULATE.ANOTHER MANUFACTURER'S WIRE GUIDE WAS USED INSTEAD WITHOUT PROBLEMS. NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7040983 ↗
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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