Cook Spectrum G44013Recalls & reported problems
Cook Incorporated · Spectrum, Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated Triple Lumen Polyurethane · Class 2
All models of Cook Spectrum (67)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002440135), received between Nov 13, 2014 and Feb 12, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Crack” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Crack1
- Other (for use when an appropriate device code cannot be identified)1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 12, 2026Crack
ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT THE PATIENT REQUIRED REMOVAL OF THE CENTRAL VENOUS CATHETER (CVC) AFTER THE LEAK WAS DISCOVERED. AFTER EVALUATING THE PATIENT POST REMOVAL, THE CARE TEAM DECIDED TO REPLACE THE CVC WITH A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24326218 ↗InjuryNov 13, 2014Other (for use when an appropriate device code cannot be identified)
THE SPECTRUM CENTRAL VENOUS CATHETER HAD BEEN FEMORAL PLACED BY THE PHYSICIAN. IT WAS NOTED (TIMELINE UNKNOWN) THAT ONE OF THE DISTAL LUMENS HAD BUBBLED UP; HOWEVER, THEY CONTINUED TO GET BLOOD RETURN. IT APPEARED THAT THERE WAS A WEAKENED AREA IN THE CATHETER CAUSING THE BUBBLE. THE CATHETER WAS REMOVED AND ANOTHER SPECTRUM CENTRAL VENOUS CATHETER WAS REMOVED AND ANOTHER SPECTRUM CENTRAL VENOUS CATHETER WAS PLACED. AT THIS TIME THE PATIENT DEVELOPED A CENTRAL LINE (PSEUDOMONAS) INFECTION. THE CATHETER WAS REMOVED AND ANOTHER MANUFACTURER'S PICC LINE WAS PLACED.
Patient problems: Unspecified Infection
MAUDE report 4258831 ↗
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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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