COUGAR® XT LVCXT190JRecalls & reported problems
Medtronic, Inc. · GDWR LVCXT190J COUGARXT CRM 5PK 190 J 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169453296), received between Aug 9, 2017 and Oct 1, 2018 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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 Fragmentation2
- Activation, Positioning or Separation Problem1
- Device Or Device Fragments Location Unknown1
- Material Integrity Problem1
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 1, 2018Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE GUIDEWIRE BROKE AND A PORTION REMAINED IN THE CORONARY SINUS. WHEN THE GUIDEWIRE PIECE WAS REMOVED, IT WAS NOTED THE DISTAL END WAS MISSING. AN INTERVENTIONIST WAS CALLED TO THE PROCEDURE AND THE REMAINING GUIDEWIRE PIECE WAS SNARED FROM THE HEART. THE IMPLANT PROCEDURE WAS THEN COMPLETED AS PLANNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7923662 ↗InjuryMay 7, 2018Material Fragmentation; Device Or Device Fragments Location Unknown; Material Fragmentation; Device Or Device Fragments Location Unknown
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DISTAL END OF THE GUIDEWIRE SHEARED OFF AND WAS LEFT IN A BRANCH OF THE CORONARY SINUS. THE IMPLANTER WAS UNABLE TO RE-ACCESS THE BRANCH TO TRY TO RETRIEVE THE FRAGMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7492786 ↗MalfunctionAug 9, 2017Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE GUIDEWIRE BECAME STUCK IN THE LEFT VENTRICULAR (LV) LEAD AND SEEMED TO WRAP ITSELF BACK INTO THE INSULATION OF THE LV LEAD. THE GUIDEWIRE STARTED TO UNRAVEL AND THE LV LEAD EXHIBITED INSULATION DAMAGE. THE LV LEAD AND GUIDEWIRE WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6781679 ↗
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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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