COUGAR® XT CGRXT300HSRecalls & reported problems
Medtronic, Inc. · GDWR CGRXT300HS COUGARXT 5PK 300 ST HY · Class 2
All models of COUGAR XT (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169452787), received between Jun 15, 2017 and Oct 20, 2020 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 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 Deformation2
- Detachment of Device or Device Component1
Patient problems
- No Consequences Or Impact To Patient2
- Device Embedded In Tissue or Plaque1
- Injury1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ONE COUGAR GUIDE WIRE WAS ATTEMPTED TO BE USED DURING A PROCEDURE TO TREAT THE DISTAL RCA. IT WAS REPORTED THAT THE TIP DETACHED WHILE IN THE PATIENT. IT WAS STATED THAT THE PHYSICIAN WAS UNABLE TO GET A STENT DOWN TO TRAP ENTIRELY. THE DETACHED PORTION REMAINS IN THE PATIENT. NO FURTHER PATIENT INJURY REPORTED.
Patient problems: Device Embedded In Tissue or Plaque; Injury; Insufficient Information
MAUDE report 10703736 ↗MalfunctionJun 15, 2017Material Deformation; Material Deformation
A COUGAR GUIDE WIRE WAS RETURNED TO THE FACILITY. IT WAS ENGAGED IN A BALLOON CATHETER INDICATING POTENTIAL USE IN THE PATIENT. NO OTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6642878 ↗MalfunctionJun 15, 2017Material Deformation; Material Deformation
PHYSICIAN INTENDED TO USE A COUGAR GUIDEWIRE. DEVICE WAS INSPECTED BEFORE USE. DEVICE WAS PREPPED BEFORE USE NO ISSUES NOTED. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. FEMORAL APPROACH WAS USED. IT IS REPORTED THAT RESISTANCE WAS EXPERIENCED DURING INSERTION. IT IS UNKNOWN IF THE RESISTANCE WAS WITH ANOTHER DEVICE OR DURING INITIAL INSERTION. PHYSICIAN DID NOT CONTINUE TO USE THE COUGAR WIRE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6642855 ↗
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- 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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