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Turbo-Ject G23900Recalls & 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
12
Deaths reported
0
Injuries reported
9
Recalls naming it
0

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00827002239005), received between Sep 14, 2017 and Dec 27, 2021 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 16, 2026.

Most reported problems

Device problems

  • Fluid/Blood Leak7
  • Material Separation6
  • Leak/Splash2
  • Adverse Event Without Identified Device or Use Problem1
  • Disconnection1
  • Split1

Patient problems

  • No Clinical Signs, Symptoms or Conditions6
  • No Code Available2
  • No Known Impact Or Consequence To Patient2
  • Bacterial Infection1
  • Insufficient Information1

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 27, 2021Leak/Splash; Material Separation; Leak/Splash; Material Separation

    NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13090630 ↗
  • InjurySep 29, 2021Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

    IT WAS REPORTED THAT THE HUB OF A TURBO-JECT® SINGLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC WAS LEAKING AND/OR SEPARATED. AS A RESULT, THE DEVICE WAS REMOVED AND REPLACED. THE DEVICE WAS PLACED IN THE PATIENT'S RIGHT ARM FOR ADMINISTRATION OF MEDICATION. NO OTHER ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12548764 ↗
  • InjurySep 29, 2021Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

    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 12548181 ↗
  • InjurySep 29, 2021Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

    IT WAS REPORTED THAT THE HUB OF A TURBO-JECT® SINGLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC WAS LEAKING AND/OR SEPARATED. AS A RESULT, THE DEVICE WAS REMOVED AND REPLACED. THE DEVICE WAS PLACED IN THE PATIENT'S RIGHT ARM FOR ADMINISTRATION OF MEDICATION. NO OTHER ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12547922 ↗
  • InjuryAug 20, 2021Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

    IT WAS REPORTED AN UNKNOWN PATIENT HAD A TURBO-JECT® SINGLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC PLACED ON (B)(6) 2021 FOR ADMINISTRATION OF IV ANTIBIOTICS THREE TIMES PER DAY. TWO MONTHS AFTER PLACEMENT AND WHILE RINSING THE LINE WITH SALINE, A PARTIAL SEPARATION AND LEAK WAS FOUND AT THE JUNCTION BETWEEN THE TUBING AND PURPLE HUB. THE LINE WAS CLAMPED AND REMOVED. THE DEVICE WAS REPLACED WITH A PERIPHERAL VENOUS CATHETER. THE PICC WAS SECURED TO THE PATIENT WITH OCCLUSIVE DRAPE AND THE PATIENT'S ACTIVITY LEVEL WAS DESCRIBED AS "ACTIVE, AUTONOMOUS IN THE GESTURES OF THE DAILY LIFE." NO OTHER ADVERSE EFFECTS WERE REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 12349102 ↗
  • InjuryJun 24, 2021Material Separation; Material Separation

    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 12062924 ↗
  • MalfunctionJun 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

    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 11958732 ↗
  • InjuryDec 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Patient problems: No Code Available

    MAUDE report 11086868 ↗
  • InjurySep 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE INTERNATIONAL CUSTOMER REPORTED THAT, 12 DAYS AFTER PLACEMENT OF THE TURBO-JECT® SINGLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER), THE PATIENT DEVELOPED A FEVER. THERE WERE NO SIGNS OF SKIN INFECTION, BUT A BLOOD CULTURE CONFIRMED THE PRESENCE OF SEPTICA PANTOEA. ANTIBIOTICS WERE ADMINISTERED, AND SUBSEQUENTLY THE PATIENT HAS REPORTEDLY HAD NO FURTHER COMPLICATIONS WITH THEIR PICC LINES. THE DEVICE WAS NOT EXPLANTED FOLLOWING THE TREATMENT OF THE INFECTION GIVEN THE POSITIVE RESPONSE TO THE ADMINISTERED MEDICATIONS; ACCORDINGLY, THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE CIRCUMSTANCES SURROUNDING THE USAGE AND HANDLING OF THE DEVICE WERE NOT REPORTED.

    Patient problems: Bacterial Infection

    MAUDE report 6893572 ↗
  • MalfunctionSep 18, 2017Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE PICC LEAKED WHEN FLUSHED. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6873201 ↗
  • MalfunctionSep 18, 2017Leak/Splash

    THERE WAS A LEAKAGE BY THE HUB WHEN THE DEVICE WAS USED FOR NUTRITION. THE PICC WAS REMOVED BECAUSE OF LEAKAGE BEFORE THE HUB. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6872436 ↗
  • InjurySep 14, 2017Disconnection; Split

    IT WAS REPORTED THE LUMEN OF PICC LINE HAD A SPLIT JUST BELOW THE HUB AND THE HUB BECAME DISCONNECTED. AS A RESULT, THE PICC LINE HAD TO BE REMOVED, TREATMENT STOPPED AND PATIENT HAD TO BE SCHEDULED TO REPLACE PICC LINE. IT WAS NOTED THE EVENT CAUSED ADDITIONAL HOSPITAL APPOINTMENTS AND LENGTHENED THE PATIENT'S HOSPITAL STAY.

    Patient problems: No Code Available

    MAUDE report 6866203 ↗

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Sources and updates

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