Turbo-Ject G23904Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002239043), received between Jul 25, 2017 and May 13, 2018 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Crack” (2 reports).
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
- Crack2
- Leak/Splash2
- Fracture1
- Split1
- Sticking1
- Unraveled Material1
Patient problems
- No Known Impact Or Consequence To Patient4
- No Code Available2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED A LEAK WAS NOTICED BELOW THE HUB OF A TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC WHILE A PATIENT WAS BEING ISSUED CHEMOTHERAPY. THE PICC LINE WAS REMOVED AND REPLACED WITH ANOTHER LIKE DEVICE TO CONTINUE TREATMENT. IT WAS REPORTED THAT WHEN IT WAS REMOVED THE NURSE FLUSHED BOTH LUMENS AND COULD NOT SEE A LEAK.
Patient problems: No Code Available
MAUDE report 7509705 ↗InjuryOct 11, 2017Crack; Leak/Splash; Crack; Leak/Splash
THE INTERNATIONAL CUSTOMER REPORTED THAT, WHILE THE TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) WAS CONNECTED TO A PUMP FOR AN INFUSION, A LEAK/CRACK IN THE MIDDLE OF THE PURPLE HUB WAS OBSERVED. THE CIRCUMSTANCES SURROUNDING THE USAGE AND HANDLING OF THE DEVICE WERE NOT REPORTED. A NEW PICC LINE HAD TO BE INSERTED. ADDITIONAL INFORMATION HAS BEE REQUESTED FROM THE CUSTOMER. THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO PRODUCT HAS YET BEEN RECEIVED FOR EVALUATION.
Patient problems: No Code Available
MAUDE report 6941592 ↗MalfunctionSep 18, 2017Fracture
THE CUSTOMER REPORTED THAT DURING A PROCEDURE TO PLACE A PICC LINE, THE WIRE TIP SHEARED AND NEARLY FRACTURED DURING MANIPULATION. NO PARTS OF THE DEVICE WERE LEFT IN THE PATIENT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6872918 ↗MalfunctionAug 30, 2017Crack; Crack
THE INTERNATIONAL CUSTOMER REPORTED THAT THE PURPLE HUB OF THE DEVICE APPEARED TO BE CRACKED, AND HAD A HOLE WHERE THE PORT CONNECTS TO THE LINE. NO PATIENT ADVERSE EVENTS WERE REPORTED BY THE CUSTOMER, AND THE CIRCUMSTANCES SURROUNDING THE USAGE AND HANDLING OF THE DEVICE ARE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6831759 ↗MalfunctionJul 28, 2017Sticking; Unraveled Material; Sticking; Unraveled Material
INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC FOR AN UNSPECIFIED INDICATION. THE CUSTOMER REPORTED OBSERVING UPON THE REMOVAL OF THE DEVICE THAT THE WIRE HAD BECOME STUCK AND UNRAVELLED. THE CUSTOMER OBTAINED A REPLACEMENT DEVICE AND COMPLETED THE PROCEDURE. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES RELATED TO THIS EVENT. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION; HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6752298 ↗MalfunctionJul 25, 2017Split; Split
INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC FOR AN UNSPECIFIED INDICATION. THE CUSTOMER REPORTED OBSERVING THAT THE DISTAL END OF THE CATHETER HAD A SPLIT. THE CUSTOMER OBTAINED A REPLACEMENT DEVICE AND COMPLETED THE PROCEDURE. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES RELATED TO THIS EVENT. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION; HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6741547 ↗
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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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