Cook Spectrum G53601Recalls & reported problems
Cook Incorporated · Spectrum, Central Venous Catheter Set Minocycline/Rifampin Antibiotic Impregnated Double Lumen Polyurethane · Class 2 · Implant
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 00827002536012), received between Dec 12, 2017 and Dec 12, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2017Difficult to Advance; Difficult to Advance
THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN THE COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER WAS BEING INTRODUCED OVER THE GUIDEWIRE FOLLOWING THE DILATION OF THE ACCESS SITE AND THE SUBSEQUENT INSERTION OF THE GUIDEWIRE, THE CATHETER COULD NOT ADVANCE OVER THE GUIDEWIRE. APPROXIMATELY 10 CM OF LENGTH OF THE PROXIMAL END PORTION OF THE DEVICE DID NOT ADVANCE. THE PROCEDURE WAS A CENTRAL VENOUS CATHETER CANNULATION OF THE RIGHT INTERNAL JUGULAR VEIN. THE PRODUCT WAS RETURNED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7107573 ↗
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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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