Cook Spectrum Turbo-Ject G23908Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002239081), received between Dec 12, 2016 and Aug 25, 2021 — classified as 4 injuries.
The most frequently reported specific device problem is “Fitting Problem” (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
- Fitting Problem2
- Fracture2
- Material Separation2
- Crack1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2021Fracture; Fitting Problem; Fracture; Fitting Problem
IT WAS REPORTED A TURBO-JECT® SINGLE LUMEN MINOCYCLINE/RIFAMPIN POWER-INJECTABLE PICC BROKE 10 DAYS AFTER INITIAL PLACEMENT. THE PATIENT WAS AT HOME RECEIVING IV MEDS WHEN HIS MOTHER NOTICED THERE WAS A CRACK IN THE DEVICE ON THE MORNING OF (B)(6) 2021. THE PATIENT WAS THEN BROUGHT INTO A LOCAL HOSPITAL AND LATER TRANSFERRED TO LURIE CHILDREN'S TO HAVE THE DEVICE REMOVED AND REPLACED WITH A SIMILAR DEVICE. NO POWER INJECTION WAS USED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12365499 ↗InjuryJul 28, 2021Crack; Fracture; Fitting Problem; Crack; Fracture; Fitting Problem
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 12240238 ↗InjuryJul 16, 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 12180378 ↗InjuryDec 12, 2016Material Separation; Material Separation
THE (B)(6) MALE PATIENT IS A MILITARY VET WITH PTSD AND LYME DISEASE. DURING A PROCEDURE, WHILE TRYING TO GET WIRE ACCESS, THE USER WAS PULLING THE WIRE BACK AND FORTH WHEN THE TIP SHEARED OFF IN THE PATIENT. THE TIP IS LODGED IN THE PATIENTS TISSUE OF HIS ARM. IT IS TO BE DETERMINED IF AND WHEN THE PIECE WILL BE REMOVED. IF REMOVED THE PHYSICIAN IS PLANNING TO DO A CUT DOWN PROCEDURE TO REMOVE THE TIP FRAGMENT.
Patient problems: Foreign Body In Patient
MAUDE report 6167197 ↗
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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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