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Turbo-Ject G34513Recalls & 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 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002345133), received between May 19, 2017 and Feb 6, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Device problems

  • Break1
  • Hole In Material1
  • Kinked1
  • Material Frayed1
  • Material Split, Cut or Torn1

Patient problems

  • No Known Impact Or Consequence To Patient2
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 6, 2019Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

    NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8312714 ↗
  • MalfunctionSep 15, 2017Material Frayed; Kinked

    THE CUSTOMER REPORTED THAT THE OPERATOR COULD NOT GET THE .010 GLIDEWIRE THROUGH THE PICC, AND THAT THE WIRE THEN FRAYED. THEY WERE ABLE TO KEEP ACCESS, BUT THE WIRE BECAME KINKED AT THE END. NO PARTS OF THE DEVICE WERE LEFT INSIDE THE PATIENT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6868788 ↗
  • MalfunctionMay 19, 2017Hole In Material; Hole In Material

    CUSTOMER REPORTED FINDING HOLES IN THE SIDE OF THE TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINES. IT IS NOT KNOWN IF THIS OBSERVATION WAS MADE PRIOR TO USE, DURING PRE-IMPLANT TESTING OR POST IMPLANTATION. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RELATING TO THE TIMING OF THE OBSERVATION, USE AND RESOLUTION / ACTIONS TAKEN TO ADDRESS THE ISSUE WAS REQUESTED. THE DEVICES INVOLVED ARE NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ANY ADDITIONAL INFORMATION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6577762 ↗

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Sources and updates

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