Cook Spectrum G43981Recalls & reported problems
Cook Incorporated · Spectrum, Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated Double Lumen Polyurethane · Class 2
All models of Cook Spectrum (67)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002439818), received between Jul 3, 2018 and Jul 3, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 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 18, 2026.
Most reported problems
Device problems
- Leak/Splash3
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.
MalfunctionJul 3, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER WAS LEAKING. AS REPORTED, IT IS UNKNOWN HOW LONG THE DEVICE WAS IN USE OR WHERE THE LEAK WAS LOCATED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7660562 ↗MalfunctionJul 3, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER WAS LEAKING. AS REPORTED, IT IS UNKNOWN HOW LONG THE DEVICE WAS IN USE OR WHERE THE LEAK WAS LOCATED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7660491 ↗MalfunctionJul 3, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER WAS LEAKING. AS REPORTED, IT IS UNKNOWN HOW LONG THE DEVICE WAS IN USE OR WHERE THE LEAK WAS LOCATED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7660124 ↗
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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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