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Cook Spectrum G51199Recalls & reported problems

Cook Incorporated · Spectrum CVC Hyperalimentation Set Minocycline/Rifampin Antibiotic Impregnated Double Lumen Silicone · 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 00827002511996), received between Sep 20, 2017 and Sep 20, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Hole In Material” (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

  • Hole In Material1

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.

  • MalfunctionSep 20, 2017Hole In Material

    THE CUSTOMER REPORTED THAT THERE WERE SMALL PINHOLES FOUND IN THE TUBING BETWEEN THE HUB AND THE JUNCTION. THIS WAS NOTICED IMMEDIATELY AFTER THE TUBE WAS PLACED, SO THEY REPLACED IT WITH A NEW DEVICE. NO PART OF THE ORIGINAL DEVICE REMAINED IN THE PATIENT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6880275 ↗

Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices

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Sources and updates

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