Cook Spectrum G57495Recalls & reported problems
Cook Incorporated · Cook Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated Power Injectable Triple Lumen · Class 2
All models of Cook Spectrum (67)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002574953), received between Nov 4, 2019 and Nov 4, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Frayed” (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.
Most reported problems
Device problems
- Material Frayed1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2019Material Frayed; Material Frayed
IT WAS REPORTED THAT THE WIRE OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAY FRAYED WHILE INSERTING THROUGH THE NEEDLE. THE ACCESS SITE FOR THE CATHETER WAS NOT REPORTED. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9272627 ↗
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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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