Cook Spectrum G21053Recalls & reported problems
Cook Incorporated · Spectrum, Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter · Class 2
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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002210530), received between Mar 22, 2018 and Jul 13, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (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-1783-2026 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗
Most reported problems
Device problems
- Difficult to Advance1
- Kinked1
- Material Twisted/Bent1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2021Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent
IN ADDITIONAL INFORMATION RECEIVED ON 17AUG2021, IT WAS REPORTED THAT THE CENTRAL LINE WAS INSERTED FOR EMERGENCY INTRAVENOUS ACCESS. IT WAS CONFIRMED THAT THE FAILURE OCCURRED DURING WIRE ADVANCEMENT. THE PATIENT HAD TO BE STUCK IN AN ADDITIONAL LOCATION TO GAIN ACCESS FOR NEW CATHETER PLACEMENT. THE PATIENT DID NOT HAVE TORTUOUS ANATOMY AND THERE WAS NO REPORTED DIFFICULTY ADVANCING THE WIRE GUIDE THROUGH THE ACCESS NEEDLE. IT WAS CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO UNINTENDED SECTION OF THE DEVICE REMAINED IN THE PATIENT AND NO HOSPITALIZATION/PROLONGED HOSPITALIZATION WAS REQUIRED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12160540 ↗MalfunctionMar 22, 2018Kinked
WHEN PATIENT HAS HAVING CENTRAL VENOUS CATHETER PLACED, THE LINE WHEN TAKEN OUT OF THE PACKAGING WAS KINKED. PHOTO ATTACHED TO THIS REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7361476 ↗
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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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