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Cook G09488Recalls & reported problems

Cook Incorporated · Yueh Centesis Disposable Catheter Needle · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002094888), received between Aug 18, 2022 and Aug 18, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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

  • Crack1
  • Leak/Splash1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 18, 2022Crack; Leak/Splash; Crack; Leak/Splash

    IT WAS REPORTED THERE WAS A CRACK IN THE HUB OF A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE AND IT LEAKED. A NEW LIKE DEVICE WAS OPENED TO SUCCESSFULLY 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 15251218 ↗

Other NEEDLE, CATHETER devices

All NEEDLE, CATHETER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.