COUGAR® LS CGRLS190HSRecalls & reported problems
Medtronic, Inc. · GDWR CGRLS190HS COUGARLS 5PK 190 ST HY · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169453319), received between Sep 27, 2019 and Aug 25, 2023 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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
- Detachment of Device or Device Component5
- Difficult to Remove1
- Entrapment of Device1
Patient problems
- Injury3
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
- Perforation1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2023Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE COUGAR GUIDEWIRE BECAME STUCK IN THE LEFT VENTRICULAR (LV) LEAD. THE COUGAR GUIDEWIRE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. THE GUIDEWIRE WAS EXAMINED AND FLUSHED BEFORE USE WITH NO ISSUES/KINKS NOTED. DIFFICULTIES WERE NOT NOTED WHEN LOADING THE GUIDEWIRE ONTO THE LEAD. THE GUIDEWIRE HAD NOT BEEN USED SUCCESSFULLY WITH OTHER DEVICES PRIOR TO DIFFICULTIES OCCURRING. THE LEAD WAS REMOVED AND REPLACED. THE GUIDEWIRE WAS REMOVED TOGETHER WITH THE LEAD. THE GUIDEWIRE WAS REPLACED WITH A MEDTRONIC DEVICE. THERE WERE NO ISSUES NOTED WITH THE REPLACEMENT GUIDEWIRE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17622254 ↗InjuryMay 11, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
AN ATTEMPT WAS MADE TO USE A COUGAR GUIDEWIRE IN A MILDLY TORTUOUS, MODERATELY CALCIFIED IN THE PROXIMAL OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 95-99% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE TIP OF THE DEVICE CAME OFF IN THE STENT. RESISTANCE WAS EXPERIENCED DURING REMOVAL. THE TIP DETACHMENT OCCURRED DURING REMOVAL. SEVERAL OPTIONS WERE TRIED TO REMOVE THE GUIDEWIRE FROM THE STENT, INCLUDING BUDDY WIRE AND BALLOON INFLATIONS. IT WAS DECIDED TO PULL IT OUT HOWEVER THE WIRE FRAGMENT WAS TRAPPED IN THE PATIENT. ANOTHER STENT WAS USED TO 'SANDWICH' IN THE WIRE. AN INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND THE DEVICE LOOKED GOOD AND SECURE. THE PATIENT WAS UNHARMED AND DID WELL AFTER THE PROCEDURE. NO FURTHER INJURY WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 14350977 ↗InjurySep 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE COUGAR GUIDEWIRE TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 95% STENOSIS LOCATED IN THE PROXIMAL, MID AND DISTAL RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUES NOTED TO THE DEVICE WHEN REMOVING FROM THE PACKAGING. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU. THE TIP WAS FORMED BY THE PHYSICIAN. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT . RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING OR WITHDRAWING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE COUGAR GUIDEWIRE WAS ADVANCED IN THE DISTAL RCA AND 3 RESOLUTE ONYX STENTS WERE DEPLOYED TO TREAT THE VESSEL. IT WAS REPORTED THAT THE UPON REMOVAL OF THE COUGAR GUIDEWIRE, THE RADIOPAQUE PORTION OF THE DISTAL END OF THE WIRE HAD DETACHED AND REMAINED IN THE DISTAL RCA. AN ATTEMPT TO SNARE THE RADIOPAQUE TIP WAS UNSUCCESSFUL. A STENT WAS DEPLOYED TO TRAP THE DETACHED SEGMENT OF THE WIRE BEHIND THE STENT. IT WAS STATED THAT A NON-MEDTRONIC WIRE WAS ADVANCED AFTER THE COUGAR GUIDEWIRE DETACHED AND RESISTANCE WAS NOTED ON REMOVAL. ANOTHE
Patient problems: Injury; Insufficient Information; Perforation
MAUDE report 10560191 ↗InjuryNov 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
A COUGAR GUIDE WIRE WAS USED DURING A PROCEDURE TO TREAT A MILDLY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES NOTED. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. THE LESION WAS PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED DURING THE PROCEDURE. IT WAS REPORTED THAT A DETACHMENT OCCURRED ON THE COUGAR DURING REMOVAL. ANOTHER WIRE WAS WRAPPED AROUND THE DETACHED PORTION AND PULLED IT INTO THE GUIDE CATHETER FOR REMOVAL. NO FURTHER PATIENT INJURY REPORTED. ONE WIRE WAS RETURNED FOR EVALUATION. PACKAGING FROM LOT G19A05977 AND FROM LOT G19A06774 WAS ALSO RETURNED. IT WAS REPORTED THAT MULTIPLE COUGARS WERE OPENED DURING THE PROCEDURE, AND IT COULD NOT BE DETERMINED WHICH PACKAGING THE DETACHED WIRE WAS FROM. (PLI20 ADDED FOR LOT G19A06774).
Patient problems: Injury
MAUDE report 9368360 ↗InjurySep 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
A COUGAR GUIDE WIRE WAS USED DURING A PROCEDURE TO TREAT A MILDLY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED DURING THE PROCEDURE. IT WAS REPORTED THAT A DETACHMENT OCCURRED ON THE COUGAR DURING REMOVAL. ANOTHER WIRE WAS WRAPPED AROUND THE DETACHED PORTION AND PULLED IT INTO THE GUIDE CATHETER FOR REMOVAL. NO FURTHER PATIENT INJURY REPORTED.
Patient problems: Injury
MAUDE report 9127591 ↗
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- 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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