Cook TPN G12022Recalls & reported problems
Cook Incorporated · Cook TPN, Double Lumen Catheter Set With 7Fr Peel-Away, Introducer Set · Class 2 · Implant
All models of Cook TPN (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002120228), received between Jan 26, 2017 and Jan 26, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Occlusion Within Device” (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
- Occlusion Within Device1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 26, 2017Occlusion Within Device; Occlusion Within Device
INFORMATION WAS PROVIDED THAT THE TRANSPLANT PATIENT HAS HAD ONGOING ISSUES WITH BLOOD BACK FLOWING INTO THE CAP OF THE BLUE LUMEN; WHICH LED TO THE LINE OCCLUDING AND REQUIRING REPLACEMENT. THE ABOVE INFORMATION IS FOR THE NEW LINE INSERTED ON (B)(6); WHICH ALSO HAD BACK FLOWING BLOOD INTO THE ICU MEDICAL MICROCALVE CAP. INTERVENTIONS TO MITIGATE THE BLOOD IN THE CAP INCLUDE TAPING / REINFORCING THE CLAMP ON THE LINE AND ADDING AN ICU MEDICAL NEUTRON (ANTI-REFLUX) CAP. THE PATIENT HAS NOT BEEN HARMED BUT HAS HAD TO HAVE 2 PROCEDURES TO REWIRE NEW CENTRAL LINES AND RECEIVED ALTEPLASE MANY TIMES DUE TO ISSUES WITH OCCLUSION IN THE LINE; THESE ALL HAVE RISK ASSOCIATED WITH THEM.
Patient problems: No Code Available
MAUDE report 6278769 ↗
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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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