Cook G08064Recalls & reported problems
Cook Incorporated · Disposable Catheter Needle · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002080645), received between Feb 1, 2021 and Aug 22, 2022 — classified as 2 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Leak/Splash1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact 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 22, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT A PATIENT REQUIRED A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE. IT WAS DISCOVERED, DURING USE, THAT THE CATHETER SPLIT, RESULTING IN LEAKAGE. NO ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15266818 ↗MalfunctionFeb 1, 2021Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11257597 ↗
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.