Cook G10100Recalls & reported problems
Cook Incorporated · Yueh Centesis Disposable Catheter Needle · Class 1
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002101005), received between Sep 2, 2020 and Mar 27, 2023 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 reports).
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
- Material Split, Cut or Torn3
- Difficult to Remove2
- Material Separation2
- Detachment of Device or Device Component1
- Device Contaminated During Manufacture or Shipping1
- Difficult to Advance1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2023Material Separation; Difficult to Advance; Material Separation; Difficult to Advance
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16622563 ↗MalfunctionOct 28, 2020Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10747869 ↗MalfunctionSep 30, 2020Difficult to Remove; Material Split, Cut or Torn; Difficult to Remove; Material Split, Cut or Torn
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE FOR A PARACENTESIS OR THORACENTESIS PROCEDURE. PRIOR TO PATIENT CONTACT, THE NEEDLE SPLIT THE TIP OF THE CATHETER. DURING ATTEMPTED REMOVAL OF THE INNER STYLET, THE NEEDLE ALSO "BACKS OUT," WHICH CAUSED THE SPLIT. THE DEVICE WAS DISCARDED AND A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10609552 ↗MalfunctionSep 30, 2020Difficult to Remove; Material Split, Cut or Torn; Difficult to Remove; Material Split, Cut or Torn
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE FOR A PARACENTESIS OR THORACENTESIS PROCEDURE. PRIOR TO PATIENT CONTACT, THE NEEDLE SPLIT THE TIP OF THE CATHETER. DURING ATTEMPTED REMOVAL OF THE INNER STYLET, THE NEEDLE ALSO "BACKS OUT," WHICH CAUSED THE SPLIT. THE DEVICE WAS DISCARDED AND A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10609539 ↗MalfunctionSep 16, 2020Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE FOR A PARACENTESIS OR THORACENTESIS PROCEDURE. PRIOR TO PATIENT CONTACT, THE NEEDLE SPLIT THE TIP OF THE CATHETER. DURING ATTEMPTED REMOVAL OF THE INNER STYLET, THE NEEDLE ALSO "BACKS OUT," WHICH CAUSED THE SPLIT. THE DEVICE WAS DISCARDED AND A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10541278 ↗MalfunctionSep 2, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 10484151 ↗MalfunctionSep 2, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 10484142 ↗
Other NEEDLE, CATHETER devices
- Cook G09490Cook Incorporated · NEEDLE, CATHETER1 recall9 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
- MAK-NV™ 00884450088838Merit Medical Systems, Inc. · NEEDLE, CATHETER4 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.