White Lumax G11165Recalls & reported problems
Cook Incorporated · Lumax Guiding Catheter · Class 2
Data updated Oct 18, 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 00827002111653), received between Jun 12, 2019 and Aug 4, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
- Fracture1
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.
MalfunctionAug 4, 2020Fluid/Blood Leak; Fluid/Blood Leak
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10361203 ↗MalfunctionJun 12, 2019Fracture; Fracture
ADDITIONAL INFORMATION WAS RECEIVED ON 14JUN2019 STATING THE TARGET SITE WAS THE PULMONARY ARTERY, AND WAS ACCESSED USING THE RIGHT COMMON FEMORAL VEIN. A .035 WIRE GUIDE WAS BEING USED DURING THE PROCEDURE. REPORTEDLY, THE PATIENT'S ANATOMY WAS NO TORTUOUS OR CALCIFIED. NO ADDITIONAL INTERVENTIONS WERE REQUIRED, THE PHYSICIAN JUST EXCHANGED THE INNER CATHETER FOR A 5 FRENCH CATHETER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8692625 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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