Turbo-Flo G12801Recalls & reported problems
Cook Incorporated · Turbo-Flo PICC Set Polyurethane Peripherally Inserted Central Venous Catheter · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002128019), received between Aug 8, 2016 and Sep 14, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance1
- Kinked1
- Unraveled Material1
Patient problems
- No Code Available1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2017Kinked; Failure to Advance
IT WAS REPORTED DURING THE PATIENT'S PICC LINE PLACEMENT PROCEDURE, THE WIRE GUIDE APPEARED TO KINK, LODGE/STICK AND WAS UNABLE TO BE ADVANCED ANY FURTHER. AS A RESULT, THE WIRE GUIDE WAS REMOVED AND ANOTHER WAS USED. IT WAS NOTED THE PATIENT EXPERIENCED ADVERSE EFFECTS AS A RESULT OF THIS EVENT. HOWEVER, NO INFORMATION WAS PROVIDED REGARDING WHAT THE ADVERSE EFFECTS WERE. ADDITIONALLY, DEVICE IMAGING IDENTIFIED BENDS AND COIL ELONGATION WITHIN THE WIRE GUIDE.
Patient problems: No Information
MAUDE report 6866399 ↗InjuryAug 8, 2016Unraveled Material; Unraveled Material
IT WAS REPORTED THAT A CENTRAL LINE WAS BEING PLACED FOR ANTIBIOTIC TREATMENT; HOWEVER, WHEN ATTEMPTING TO REMOVE THE GUIDE-WIRE TO PLACE THE LINE, THE WIRE UNRAVELED AND/OR KNOTTED AND COULD NOT BE REMOVED. SURGERY WAS PERFORMED TO REMOVE THE WIRE FROM THE PATIENT. THE PATIENT WAS IN STABLE CONDITION AND WAS REFERRED TO ANOTHER FACILITY TO HAVE A CENTRAL LINE PLACED.
Patient problems: No Code Available
MAUDE report 5852954 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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