COUGAR® XT CGRXT190JRecalls & reported problems
Medtronic, Inc. · GDWR CGRXT190J COUGARXT 5PK 190 J SIL · Class 2
All models of COUGAR XT (7)
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 00643169452817), received between Aug 17, 2017 and Aug 17, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Entrapment of Device” (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
- Entrapment of Device1
- 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.
MalfunctionAug 17, 2017Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE WHEN POSITIONING THE LEFT VENTRICULAR LEAD IN THE IN DISTAL CORONARY SINUS POSTEROLATERAL VENE, THE GUIDEWIRE WAS STUCK INSIDE THE LEAD AND DID NOT GO FORWARD OR BACKWARDS. THE ARTERY HAD SEVERE TORTUOSITY. NO ISSUES WERE NOTED WITH THE COUGAR WIRE PACKAGING. NO ISSUES REPORTED WHEN REMOVING THE WIRE FROM THE PACKAGING PER IFU. THE WIRE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES NOTED. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. THE LEAD WAS REMOVED WITH THE WIRE FIXED INSIDE. THE WIRE COULD BE REMOVED OUTSIDE OF THE BODY WHEN FORCE WAS APPLIED. THE COUGAR WIRE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE WIRE. EXCESSIVE FORCE WAS NOT APPLIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6799808 ↗
Other WIRE, GUIDE, CATHETER devices
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- 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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