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Cook Spectrum Turbo-Ject G34553Recalls & reported problems

Cook Incorporated · Cook Spectrum Turbo-Ject PICC Set Minocycline/Rifampin Impregnated Power Injectable Polyurethane Peripherally Inserted Central Venous Catheter · Class 2 · Implant

All models of Cook Spectrum Turbo-Ject (12)

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

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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002345539), received between Dec 7, 2017 and May 13, 2022 — classified as 3 injuries.

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 18, 2026.

Most reported problems

Device problems

  • Break1
  • Detachment of Device or Device Component1
  • Fluid/Blood Leak1
  • Leak/Splash1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Code Available1

Recent adverse event reports

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

  • InjuryMay 13, 2022Break; Leak/Splash; Break; Leak/Splash

    IT WAS REPORTED A TURBO-JECT® SINGLE LUMEN MINOCYCLINE/RIFAMPIN POWER-INJECTABLE PICC SEPARATED AND/OR LEAKED ON 18OCT2021. THE DEVICE WAS REMOVED AND REPLACED. THE ISSUE ALSO RESULTED IN A NEED FOR INCREASED MONITORING. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14402067 ↗
  • InjuryApr 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11685413 ↗
  • InjuryDec 7, 2017Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE END OF THE FIRST ORANGE HUB OF THE TURBO-JECT® SINGLE LUMEN MINOCYCLINE/RIFAMPIN POWER-INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) WAS LEAKING. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ONCE THE LEAK WAS NOTICED, AND THEN WENT TO THE OPERATING ROOM FOR A REPLACEMENT THAT SAME DAY. THE CUSTOMER LATER CLARIFIED THAT THE HUB ITSELF WAS NOT CRACKED, BUT RATHER THE TUBING AT THE HUB WAS WHAT LEAKED. THE CATHETER HAD BEEN IMPLANTED ABOUT 3 MONTHS. THE CATHETER LUMEN WITH THE FAILED HUB WAS USED FOR THE INJECTION OF DRUGS AND FOR BLOOD WITHDRAWAL. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

    Patient problems: No Code Available

    MAUDE report 7098021 ↗

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Sources and updates

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