Cook Spectrum G51537Recalls & reported problems
Cook Incorporated · Spectrum, Central Venous Catheter Set Minocycline/Rifampin Antibiotic Impregnated 5 Lumen Polyurethane · Class 2 · Implant
All models of Cook Spectrum (67)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002515376), received between Jan 14, 2020 and Jan 14, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unraveled Material” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Mar 5, 2026Open, Classified
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1788-2026 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗
Most reported problems
Device problems
- Unraveled Material1
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.
MalfunctionJan 14, 2020Unraveled Material; Unraveled Material
IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING WITHDRAWAL OF THE WIRE GUIDE IN A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED FIVE LUMEN CENTRAL VENOUS CATHETER SET DURING A CVC REPLACEMENT. THE LINE WAS INSERTED INTO THE RIGHT AXILLARY/SUBCLAVIAN REGION OF A BURN PATIENT AFTER AN OPERATIVE PROCEDURE. THE VESSEL WAS REPORTED TO BE DILATED. RESISTANCE WAS NOTED AT APPROXIMATELY 20 CM AND THE CATHETER WAS UNABLE TO BE PASSED OVER THE GUIDE WIRE. WHEN THE WIRE WAS BEING WITHDRAWN, UNCOILING IN THE WIRE WAS NOTED. ULTIMATELY, THE INSERTION WAS ABANDONED AND MOVED TO THE OTHER SIDE. THE VASCULAR TEAM REMOVED THE GUIDE WIRE SUCCESSFULLY AND THE PATIENT WAS TAKEN TO THE ICU. EXTUBATION WAS DELAYED TO "ENSURE THAT THE PATIENT DID NOT COUGH OR STRAIN CAUSING BLEEDING". NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. THE PRODUCT WILL NOT BE RETURNED, AS IT HAS BEEN DISCARDED BY THE FACILITY "DUR" TO CONTAMINATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9587344 ↗
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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 · each recall links to the FDA recall notice
- 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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