Cook G09492Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002094925), received between Jun 9, 2017 and Jan 2, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE CATHETER FROM A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE SEPARATED. 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 21057624 ↗
• MalfunctionDec 27, 2024

  DURING CHEST TUBE PLACEMENT, A SOFT DISTAL TIP OF NEEDLE'S PLASTIC OUTER CATHETER (4MM FRAGMENT) WAS SHEARED OFF AND REMAINED WITHIN THE PATIENT'S PLEURAL SPACE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21025871 ↗
• MalfunctionAug 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE BROKE AT THE HUB DURING A PERCUTANEOUS ABSCESS DRAINAGE PROCEDURE ON A 73-YEAR-OLD MALE PATIENT. THE USER OPENED A NEW DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. A PHOTO PROVIDED BY THE CUSTOMER CONFIRMS DETACHMENT OF THE HUB FROM THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324541 ↗
• MalfunctionJun 13, 2022Material Separation; Material Separation

  IT WAS REPORTED THE CATHETER HUB OF A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE SEPARATED. THE DEVICE REQUIRED FOR A PARACENTESIS TO DRAIN ASCITES AND WAS PLACED VIA DIRECT STICK IN THE PATIENT'S ABDOMEN. DURING THE PROCEDURE, THE HUB OF THE CATHETER SEPARATED. NO PORTION OF THE DEVICE WAS RETAINED IN THE PATIENT. IT WAS NOTED THAT NO FORCE WAS EXERTED ON THE CATHETER. 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 14675636 ↗
• InjuryMay 18, 2018Material Separation; Material Separation

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 7525038 ↗
• MalfunctionSep 28, 2017Break; Break

  THE CUSTOMER REPORTED THAT, WHEN USING THE YUEH CENTESIS DISPOSABLE CATHETER NEEDLE INSIDE THE PATIENT DURING A THORACENTESIS, IT WAS IDENTIFIED THAT APPROXIMATELY 1 CM OF THE TIP OF THE CATHETER HAD BROKEN, AND APPEARED TO BE PERMANENTLY BENT. THIS WAS DISCOVERED AFTER THE NEEDLE WAS REMOVED FROM THE DEVICE, AND NO FLUID RETURNED AS EXPECTED. THE CIRCUMSTANCES SURROUNDING THE USAGE AND HANDLING OF THE DEVICE ARE NOT KNOWN. THE CUSTOMER CONFIRMED THAT NO PIECES OF THE CATHETER REMAINED IN THE PATIENT, AND NO ADDITIONAL PROCEDURES WERE NECESSARY AS A RESULT OF THE ISSUE. THE PATIENT REPORTEDLY DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE PRODUCT PROBLEM. THE PRODUCT IS REPORTEDLY NOT AVAILABLE FOR RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6902053 ↗
• InjuryJun 9, 2017Break; Break

  CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING A CHOLANGIOGRAM USING A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE. THE NEEDLE REPORTEDLY BROKE OFF IN THE PATIENT. THE ACTIVITIES TO ADDRESS THE EVENT AT THE TIME WERE NOT PROVIDED. THE PATIENT WAS RETURNED TO SURGERY LATE IN THE NIGHT TO EVACUATE A HEMATOMA. THE CUSTOMER REPORTS THAT THE PATIENT MAY BE RETURNED FOR ADDITIONAL UNSPECIFIED SURGERY. IT IS NOT KNOWN IF ANY UNINTENDED PORTION OF THE DEVICE IS RETAINED WITHIN THE PATIENTS' BODY. NO FURTHER EVENT OR PATIENT INFORMATION IS AVAILABLE AS OF THE DATE OF THIS REPORT. THE DEVICE THAT IS THE SUBJECT OF THIS REPORT WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hematoma; No Code Available

  MAUDE report 6629490 ↗