Cook Spectrum G50819Recalls & 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 16, 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 00827002508194), received between Sep 25, 2017 and Jan 8, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Kinked” (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
- Kinked2
- Unraveled Material2
- Failure to Advance1
- Stretched1
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.
MalfunctionJan 8, 2018Kinked; Unraveled Material; Kinked; Unraveled Material
THE CUSTOMER REPORTED THAT, DURING A CENTRAL LINE INSERTION PROCEDURE IN WHICH THE SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER WAS EMPLOYED, THE WIRE GOT HUNG UP ON THE NEEDLE. THIS REPORTEDLY CAUSED THE WIRE GUIDE TO KINK AND UNRAVEL. A SMALLER WIRE GUIDE WAS ULTIMATELY USED TO COMPLETE THE PROCEDURE, AND THE CUSTOMER CONFIRMED THAT THE PRODUCT MALFUNCTION DID NOT NECESSITATE ANY ADDITIONAL PROCEDURES OR RESULT IN ANY PATIENT ADVERSE EVENTS. THE DEVICE HAS REPORTEDLY BEEN DISPOSED OF AND IS UNAVAILABLE FOR RETURN AND EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7173923 ↗MalfunctionSep 27, 2017Kinked; Unraveled Material
IT WAS REPORTED THAT THE CENTRAL LINE WAS BEING PLACED FOR HEART SURGERY AND THE WIRE KINKED. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THE WIRE UNRAVELED WHEN IT WAS REMOVED AND IT COULD HAVE KINKED, BUT THE CUSTOMER COULD NOT CONFIRM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6896977 ↗MalfunctionSep 25, 2017Stretched; Failure to Advance
THE CUSTOMER REPORTED THAT WHILE PLACING A CENTRAL LINE IN A PATIENT, THEY ENCOUNTERED RESISTANCE WHILE ADVANCING THE GUIDEWIRE THROUGH THE CATHETER. THEY WEREN¿T SURE IF THE WIRE WAS BEING OBSTRUCTED IN THE CATHETER OR THE PATIENT, BUT WHEN THEY TRIED TO REMOVE THE WIRE, IT CAUGHT AGAIN AND BEGAN STRETCHING. THEY THEN REMOVED THE GUIDEWIRE AND CATHETER TOGETHER, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE REPORTER ALSO CHECKED THE COMPLAINT DEVICE AFTER THE PROCEDURE AND ALLEGED THAT LUMEN OF THE CATHETER WAS ABNORMAL AND NARROW, CAUSING RESISTANCE FOR THE GUIDEWIRE. NO PART OF THE COMPLAINT DEVICE WAS LEFT IN THE PATIENT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6890313 ↗
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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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