COUGAR® XT CGRXT190SRecalls & reported problems
Medtronic, Inc. · GDWR CGRXT190S COUGARXT 5PK 190 ST SIL · Class 2
All models of COUGAR XT (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169452800), received between Nov 9, 2017 and Jun 10, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Entrapment of Device1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2019Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT AN ATAIN ABILTIY PLUS LEAD AND A COUGAR GUIDE WIRE WERE USED DURING A PROCEDURE IN THE LEFT MAIN CORONARY ARTERY, EXHIBITING NO TORTUOUSITY AND NO CALCIFICATION. NO DAMAGE NOTED TO PACKAGING, NO ISSUES REMOVING THE DEVICE FROM PACKAGING AS PER IFU. THE COUGAR WAS INSPECTED WITH NO ISSUES, BUT WAS NOT PREPPED PER IFU. THE COUGAR WAS FLUSHED BEFORE USING. THE WIRE TIP WAS FORMED A LITTLE BY THE PHYSICIAN. THE LESION WAS NOT PRE-DILATED, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT IS REPORTED THAT SOME RESISTANCE WAS EXPERIENCED WHEN PUTTING THE LEAD OVER THE WIRE, DURING USE AND DURING REMOVAL. THE LEAD WAS COMPLETELY EXPLANTED - THE COUGAR WIRE COULD NOT BE REMOVED FROM THE LEAD BODY. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8682784 ↗MalfunctionNov 9, 2017Break; Material Deformation; Break; Material Deformation
THE PHYSICIAN INTENDED TO USE A COUGAR GUIDEWIRE. THERE WAS NO DAMAGE NOTED TO PACKAGING. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. THE DEVICE WAS USED DURING A PROCEDURE IN A MID SAPHENOUS VEIN GRAFT, EXHIBITING MODERATE TORTUOSITY. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. IT IS NOTED THAT THE DEVICE LOOKED DAMAGED WHEN RETRIEVED FROM THE PATIENT. IT IS NOTED THAT THE DEVICE HAD STRETCHED COILS DURING REMOVAL. THERE IS NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7013343 ↗
Other WIRE, GUIDE, CATHETER devices
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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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