Cook G09490Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002094901), received between Feb 25, 2015 and Apr 19, 2022 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 1, 2024Open, Classified

   Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

   Z-1527-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A MALE PATIENT REQUIRED PLACEMENT OF A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE FOR AN OUTPATIENT PARACENTESIS PROCEDURE. DURING THE PROCEDURE, THE CATHETER BROKE OFF AT THE HUB AS THE USER CONNECTED THE CATHETER TO THE SUCTION TUBING. THE CATHETER WAS EXTENDING OUTSIDE OF THE PATIENT'S ABDOMEN AND THE USER REMOVED THE CATHETER USING THE WIREGUIDE. A NEW CATHETER WAS PLACED. 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 14141099 ↗
• MalfunctionApr 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE SEPARATED. THE DEVICE WAS PLACED VIA PERIPHERAL DIRECT STICK IN THE BELLY FOR ASCITES DRAINAGE. AT THE END OF THE PROCEDURE, DURING REMOVAL, THE HUB OF THE CATHETER SEPARATED FROM THE TUBING. THE PROCEDURE WAS COMPLETED WITH THE COMPLAINT DEVICE. THE FITTING WAS SECURELY ATTACHED AT FIRST INSPECTION AND WAS CONNECTED TO A DRAINAGE VESSEL. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14000759 ↗
• MalfunctionMar 4, 2021Detachment of Device or Device Component; 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: Foreign Body In Patient

  MAUDE report 11415542 ↗
• InjuryMay 21, 2020Material Separation; Material Separation

  IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED PLACEMENT OF A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE FOR AN UNKNOWN PROCEDURE. AS THE OPERATOR REMOVED THE CATHETER, IT WAS NOTED THAT APPROXIMATELY 1 CM "BROKE OFF JUST UNDER THE PATIENT'S SKIN". THERE ARE NO PLANS TO REMOVE THE FRAGMENT FROM THE BODY. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 10078691 ↗
• MalfunctionJan 29, 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 9643918 ↗
• InjuryDec 12, 2019Material Separation; Material Separation

  IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED PLACEMENT OF A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE FOR AN ASCITES DRAINAGE PROCEDURE. DURING THE PROCEDURE, THE OPERATOR "MADE MULTIPLE PASSES AND REPOSITIONS" TO PROPERLY DRAIN THE ASCITES. UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT "~1 INCH SEGMENT" OF THE CATHETER WAS RETAINED IN THE RIGHT UPPER QUADRANT OF THE PATIENT, AS CONFIRMED BY POST PROCEDURE RADIOGRAPH. A PRECAUTIONARY SURGICAL CONSULT WAS OBTAINED. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9460281 ↗
• MalfunctionJul 18, 2017Split; Split

  CUSTOMER REPORTED THAT THE CATHETER OF A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE SPLIT DURING AN ABDOMINAL ASPIRATION PROCEDURE. THE DEVICE WAS CONNECTED AND WAS SUCKING IN AIR AT THE SPLIT ON THE PROXIMAL END OF THE DEVICE. ANOTHER DEVICE WAS OBTAINED TO COMPLETE THE ASPIRATION. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE DEVICE WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6721171 ↗
• InjuryDec 19, 2016Material Separation; Material Separation

  IT WAS REPORTED WHEN THE RADIOLOGIST WAS PULLING BACK ON THE DEVICE, THE HUB DETACHED. THE PORTION OF THE DEVICE REMAINS INSIDE THE PATIENT AT THIS TIME. THE RADIOLOGIST CONSULTED WITH THE SURGEON AND THE CASE IS NOW WITH THE SURGEON. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6186004 ↗
• InjuryFeb 25, 2015Material Separation

  DURING A PARACENTESIS PROCEDURE ON A (B)(4) PT, UPON REMOVING THE CATHETER FROM THE PT, THE CATHETER SHEARED, LEAVING APPROX 6 CM OF THE CATHETER INSIDE THE PT. A LARGER HOLE NEEDED TO BE CREATED IN ORDER TO REMOVE THE DEVICE PORTION FROM THE PT VIA FORCEPS.

  Patient problems: Foreign body, removal of

  MAUDE report 4561898 ↗