Cook TPN G32440Recalls & reported problems
Cook Incorporated · Cook TPN, Double Lumen Catheter Set With 11Fr Peel-Away, Introducer Set · Class 2 · Implant
All models of Cook TPN (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002324404), received between Apr 16, 2018 and Apr 16, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN FLUSHING THE REDO DOUBLE LUMEN TPN CATHETER WHICH WAS IMPLANTED ON (B)(6) 2017, ON (B)(6) 2018 THE CATHETER WAS LEAKING LIQUID AT THE CONNECTION BETWEEN THE BLUE PART AND THE CLAMP SCREW. THE CATHETER WAS REPORTED TO HAVE BEEN REMOVED, A NEW CATHETER WAS NOT IMPLANTED. DOCTORS "WAIT AND SEE". 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 7432622 ↗
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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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