Turbo-Ject G34517Recalls & reported problems

Cook Incorporated · Turbo-Ject PICC Set Power Injectable Polyurethane Peripherally Inserted Central Venous Catheter · Class 2 · Implant

All models of Turbo-Ject (40)

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

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002345171), received between May 7, 2018 and Jun 23, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other 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 18, 2026.

Most reported problems

Device problems

Device Contamination with Chemical or Other Material1
Fluid/Blood Leak1
Fracture1
Material Separation1

Patient problems

Hemorrhage/Blood Loss/Bleeding1
No Patient Involvement1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryJun 23, 2022Fluid/Blood Leak; Fracture; Material Separation; Fluid/Blood Leak; Fracture; Material Separation
IT WAS REPORTED A PATIENT REQUIRED REPLACEMENT OF A TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC. THE CATHETER EXTENSION TUBE WAS FOUND TO BE DETACHED FROM THE HUB, AND "SLIGHT BLEEDING" WAS REPORTED. THE PICC WAS SUCCESSFULLY REPLACED BY ANESTHESIA DURING AN ADDITIONAL PROCEDURE IN THE OPERATING ROOM. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 14788059 ↗
MalfunctionMay 7, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED AN ANESTHETIST OPENED A TURBO-JECT® SINGLE LUMEN BEDSIDE POWER-INJECTABLE PICC DURING PRE-OP AND DISCOVERED TWO SMALL PIECES OF RUBBER IN THE PACKAGE. A NEW KIT WAS OPENED AND USED TO COMPLETE THE SCHEDULED PROCEDURE. AS REPORTED, THIS FOREIGN MATTER WAS DISCOVERED PRIOR TO USE.
Patient problems: No Patient Involvement
MAUDE report 7489805 ↗

Device details

UDI-DI	`00827002345171`
Brand	Turbo-Ject
Model	G34517
Catalog no.	UPICS-4.0-CT-40NT-1111
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	Not in Commercial Distribution
Record updated	Feb 3, 2022

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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All Catheter,intravascular,therapeutic,long-term greater 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
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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