Cook G09489Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002094895), received between Aug 7, 2019 and Aug 30, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A SEPARATION OCCURRED AT THE TRANSITION OF THE PLASTIC CATHETER AND HUB OF A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE DURING A PARACENTESIS PROCEDURE FOR A PATIENT OF UNDISCLOSED AGE AND GENDER. THE SEPARATED PORTION OF THE CATHETER WAS STICKING OUT OF THE SKIN AND THE OPERATOR GRABBED THE CATHETER PIECE WITH THEIR FINGERS TO REMOVE IT COMPLETELY FROM THE PATIENT. A SECOND, SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. IT WAS REPORTED THAT NO FORCE WAS EXERTED ON THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321748 ↗
• MalfunctionAug 17, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A SEPARATION OCCURRED AT THE TRANSITION OF THE PLASTIC CATHETER AND HUB OF A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE DURING A PARACENTESIS PROCEDURE FOR A PATIENT OF UNDISCLOSED AGE AND GENDER. THE SEPARATED PORTION OF THE CATHETER WAS STICKING OUT OF THE SKIN AND THE OPERATOR GRABBED THE CATHETER PIECE WITH THEIR FINGERS TO REMOVE IT COMPLETELY FROM THE PATIENT. A SECOND LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. IT WAS REPORTED THAT NO FORCE WAS EXERTED ON THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15244504 ↗
• MalfunctionJun 17, 2022Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE SEPARATED. DURING AN IMAGE-GUIDED PARACENTESIS, THE DEVICE WAS PLACED IN THE PATIENT AND IMMEDIATELY BEGAN LEAKING. THEN THE HUB DISCONNECTED AND THE CATHETER NEEDLE WAS REMOVED IN ITS ENTIRETY FROM THE PATIENT. A NEW DEVICE WAS OBTAINED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14733090 ↗
• MalfunctionApr 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE SEPARATED. THE DEVICE WAS REQUIRED FOR A COMPUTED TOMOGRAPHY (CT) GUIDED DRAIN PLACEMENT INTO A PELVIC ABSCESS AND WAS PLACED VIA DIRECT STICK. AS THE PHYSICIAN WAS REMOVING THE DEVICE, AND THE HUB BROKE OFF. THE DEVICE WAS THEN REMOVED IN ITS ENTIRETY, AS THE ACCESS WIRE WAS STILL IN PLACE. THE PROCEDURE WAS COMPLETED "AS NORMAL" AND PATIENT OUTCOME WAS "AS EXPECTED". THE CUSTOMER NOTED THERE WAS NO DIFFICULT ADVANCEMENT OR FORCE EXERTED ON THE DEVICE. NO OBSTRUCTIONS WERE ENCOUNTERED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13986529 ↗
• InjuryAug 7, 2019Crack; Crack

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available; Pneumothorax

  MAUDE report 8869241 ↗