Cook Spectrum G47827Recalls & reported problems

Cook Incorporated · Spectrum, Central Venous Catheter Set Minocycline/Rifampin Antibiotic Impregnated Triple Lumen Polyurethane · Class 2 · Implant

All models of Cook Spectrum (67)

Data updated Oct 18, 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: 8
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002478275), received between Sep 25, 2017 and Jan 26, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Crack” (4 reports).

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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Mar 5, 2026Class IIOpen, 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

Crack4
Fluid/Blood Leak4
Fracture2
Bent1
Device Contaminated During Manufacture or Shipping1
Kinked1
Material Integrity Problem1
Obstruction of Flow1

Patient problems

Insufficient Information4
No Clinical Signs, Symptoms or Conditions4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 26, 2026Crack
IT WAS REPORTED THAT THE WHITE HUB OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET WAS CRACKED. AFTER REPOSITIONING THE PATIENT, IT WAS NOTED THAT THE PATIENT'S GOWN WAS WET ON THE RIGHT FEMORAL SIDE, INITIALLY THOUGHT TO BE DUE TO SWEATING OR A POSSIBLE SPILL DURING THE TURNS. DURING PREPARATION FOR INTRAVENOUS MEDICATION ADMINISTRATION VIA THE CENTRAL VENOUS LINE, THE WHITE PORT WAS FLUSHED, RESULTING IN FLUID SPRAYING OUT. CLOSER INSPECTION REVEALED A CRACK IN THE PORT, WITH FLUID LEAKING. THE PORT WAS IMMEDIATELY CLAMPED, COVERED WITH A RED STOPPER, AND MARKED WITH AN ORANGE WARNING STICKER TO INDICATE IT SHOULD NOT BE USED. THE "ACNM AND ICU REGISTRAR" WERE NOTIFIED WHO ADVISED CLAMPING AND LABELING THE DEFECTIVE PORT AND CONTINUING USE OF THE UNAFFECTED PORTS. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24182962 ↗
InjuryOct 31, 2024Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE WHITE HUB FROM A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET WAS OCCLUDED. AFTER THE DEVICE WAS PLACED IN THE INTERNAL JUGULAR VEIN, NORMAL SALINE WAS USED TO TEST THE CATHETER, AND IT WAS DISCOVERED THAT THE WHITE HUB WAS "BLOCKED". AS A RESULT, THE DEVICE WAS REMOVED AND A NEW "CVP" WAS PLACED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20579813 ↗
MalfunctionMay 6, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE BLUE HUB OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET LEAKED. THE CATHETER WAS INSERTED IN EITHER THE SUBCLAVIAN OR FEMORAL VEIN. IT IS THE FACILITY'S STANDARD PRACTICE TO ATTACH A COMPETITOR'S 3-WAY TAP TO ALL LUMENS. THE CATHETER WAS INFUSING TOTAL PARENTERAL NUTRITION (TPN) AND/OR NORADRENALINE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19255667 ↗
MalfunctionMay 6, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 19255440 ↗
MalfunctionMay 1, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19221134 ↗
MalfunctionDec 8, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 18290386 ↗
InjuryNov 13, 2023Crack; Fluid/Blood Leak; Fracture; Crack; Fluid/Blood Leak; Fracture
IT WAS REPORTED THE HUB OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET CRACKED AND THE LINE LEAKED. THE PATIENT WAS SEDATED AND VENTILATED. THE PORTS OF THE DEVICE WERE USED FOR SEDATION AND INTRAVENOUS (IV) FLUID MANAGEMENT. AS TIME PROGRESSED, THE PATIENT BECAME AGITATED AND DIFFICULT TO MANAGE DESPITE INCREASING DOSES OF SEDATION. THE BED LINEN AND GARMENTS WERE NOTICED TO BE WET, AND IT WAS DISCOVERED THE DEVICE WAS LEAKING RESULTING IN THE PATIENT NOT RECEIVING ALL OF THE MEDICATION. THEREFORE, THE SEDATION LINE WAS CHANGED TO A PERIPHERAL IV ACCESS AND INFUSION RECOMMENCED. UPON CLOSER INSPECTION OF THE CENTRAL CATHETER, A CRACK WAS VISIBLE ON THE HUB OF THE WHITE PORT. THE COMPLAINT DEVICE WAS REMOVED AND REPLACED WITH ANOTHER CENTRAL LINE FOR CONTINUED IV ACCESS. IT IS UNKNOWN HOW LONG THE COMPLAINT DEVICE HAD BEEN IN PLACE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18119077 ↗
MalfunctionSep 25, 2017Bent; Kinked; Material Integrity Problem
IT WAS REPORTED DURING THE PATIENT'S CVC INSERTION PROCEDURE (SUBCLAVIAN VEIN), THE DILATORS WERE TOO SOFT AND WOULD BEND, WIRE KINKING OCCURRED AND THE WIRE JAMMED IN THE PATIENT'S VEIN. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURE AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6891456 ↗

Device details

UDI-DI	`00827002478275`
Brand	Cook Spectrum
Model	G47827
Catalog no.	C-UTLM-701J-LSC-ABRM-HC-RD
Company	Cook Incorporated
Product code	FOZ · Catheter,intravascular,therapeutic,short-term less than 30 days
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 19, 2021

Device type (GMDN): Centrally-inserted central venous catheter

A flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. This is a single-use device.

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All Catheter,intravascular,therapeutic,short-term less than 30 days devices →

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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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