Cook Spectrum G36206Recalls & reported problems

Cook Incorporated · Cook Spectrum PICC Set Minocycline/Rifampin Impregnated Silicone Peripherally Inserted Central Venous Catheter · Class 2 · Implant

All models of Cook Spectrum (67)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002362062), received between Sep 20, 2017 and Sep 20, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (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 18, 2026.

Most reported problems

Device problems

Leak/Splash1

Patient problems

No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjurySep 20, 2017Leak/Splash
THE CUSTOMER REPORTED THAT 12 HOURS AFTER PLACEMENT, THE DEVICE BEGAN TO LEAK AT THE CONNECTOR, NECESSITATING REPLACEMENT OF THE DEVICE. THERE WERE NO FURTHER INJURIES ASIDE FROM THE REPLACEMENT PROCEDURE.
Patient problems: No Code Available
MAUDE report 6880785 ↗

Device details

UDI-DI	`00827002362062`
Brand	Cook Spectrum
Model	G36206
Catalog no.	C-PICS-401J-ABRM
Company	Cook Incorporated
Product code	LJS · Catheter,intravascular,therapeutic,long-term greater 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): Peripherally-inserted central venous catheter

A thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

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

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