Cook Spectrum G43991Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002439917), received between Dec 19, 2016 and Mar 11, 2025 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (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.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow2
- Complete Blockage1
- Crack1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
- No Code Available1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE PROXIMAL PORT OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER WAS FOUND TO BE OCCLUDED. AT THIS TIME, NO HARM TO THE PATIENT HAS BEEN REPORTED. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21573316 ↗MalfunctionMay 24, 2024Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE BLUE LUMEN OF THE COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER WAS FOUND TO BE OCCLUDED DURING A SUBCLAVIAN PROCEDURE ON AN UNDISCLOSED PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW LIKE DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19393593 ↗InjuryJul 28, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CATHETER FROM A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER TRAY LEAKED AROUND THE INSERTION SITE. THE DEVICE WAS PLACED IN THE PATIENT AND SECURED WITH SUTURE. WHEN THE BLUE LUMEN WAS FLUSHED, LEAKAGE AROUND THE INSERTION SITE WAS NOTED. AS A RESULT, THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE WITH INCREASED SEDATION TO REPLACE THE CATHETER. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: Insufficient Information
MAUDE report 17414480 ↗MalfunctionMar 23, 2021Complete Blockage; Complete Blockage
IN ADDITIONAL INFORMATION RECEIVED ON 01APR2021, IT WAS CONFIRMED THAT THE DEVICE WAS REMOVED AND REPLACED IN THE SAME PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11554156 ↗InjuryDec 19, 2016Crack; Crack
PER THE MW14 02760000-2016-8031 , REPORTED THROUGH THE FDA VOLUNTARY EVENT REPORTING PROCESS, THE MANUFACTURER WAS INFORMED THAT: AFTER THE CENTRAL LINE WAS PLACED, THE WHITE LUMEN WAS NOTED TO BE CRACKED WHERE THE HUB MEETS THE TUBING RESULTING IN THE NEED FOR AN ADDITIONAL PROCEDURE.
Patient problems: No Code Available
MAUDE report 6186163 ↗
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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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