Kellett G20155Recalls & reported problems
Cook Incorporated · Kellett Translucent Drainage Access Catheter with Echotip Needle · Class 1
- 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 00827002201552), received between Oct 8, 2015 and Aug 14, 2018 — classified as 1 injury, 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Material Separation1
Patient problems
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2018Break
IT WAS REPORTED THAT THE KELLETT DRAINAGE ACCESS CATHETER NEEDLE SNAPPED DURING THE PROCEDURE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, BUT THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7782700 ↗InjuryOct 8, 2015Material Separation
DURING THE TRANSVAGINAL DRAINAGE OF ABSCESS PROCEDURE THE ABSCESS WAS PUNCTURED WITH A KELLETT NEEDLE AS ROUTINE. THE STILLETTE WAS WITHDRAWN, BUT THEN PUSHED BACK AGAIN TO VERIFY THE POSITION BEFORE REMOVAL. THE WIRE WAS THEN INSERTED THROUGH THE CANNULA, BUT IT COILED IN THE VAGINA INSTEAD OF IN THE ABSCESS. THE CANNULA WAS WITHDRAWN AND 5CM OF CATHETER WAS SEEN TO BE MISSING. THE DETACHED END WAS FOUND IN THE VAGINA, IT WAS ASSUMED TO BE LEFT IN THE ABSCESS CAVITY. A NEW NEEDLE WAS USED TO RE-PUNCTURE AND DRAIN THE ABSCESS. ADDITION INFORMATION HAS BEEN REQUESTED, HOWEVER IT WAS NOT PROVIDED AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 5136891 ↗
Other NEEDLE, CATHETER devices
- Cook G09490Cook Incorporated · NEEDLE, CATHETER1 recall9 reports
- Cook G10100Cook Incorporated · NEEDLE, CATHETER7 reports
- Cook G09492Cook Incorporated · NEEDLE, CATHETER7 reports
- MAK-NV™ 00884450013588Merit Medical Systems, Inc. · NEEDLE, CATHETER6 reports
- Cook G09489Cook Incorporated · NEEDLE, CATHETER5 reports
- MAK-NV™ 00884450088791Merit Medical Systems, Inc. · NEEDLE, CATHETER5 reports
- Ring G03388Cook Incorporated · NEEDLE, CATHETER5 reports
- Skater™ Introducer System 651506300Argon Medical Devices, Inc. · Needle, Catheter5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.