Cook G14519Recalls & reported problems
Cook Incorporated · Fascial Incising Needle Use with wire guide .038 · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002145191), received between Jan 13, 2022 and Apr 13, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Contamination1
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2023Contamination; Contamination
IT WAS REPORTED THAT THREE FASCIAL INCISING NEEDLES FROM THE SAME LOT WERE OPENED AND ALL HAD A WHITE MATERIAL ON THE NEEDLE. NONE OF THE DEVICES MADE PATIENT CONTACT. A FOURTH FASCIAL INCISING NEEDLE FROM ANOTHER LOT WAS OPENED AND USED FOR THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16732440 ↗MalfunctionJan 13, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED, DURING A PERCUTANEOUS NEPHROLITHONOMY, A FASCIAL INCISING NEEDLE WAS OPENED AND IT APPEARED TO BE CONTAMINATED ON THE WINGED AREA. ANOTHER ONE WAS OPENED FROM THE SAME LOT AND IT ALSO APPEARED TO BE CONTAMINATED ON THE WINGED AREA. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13252255 ↗
Other NEEDLE, GASTRO-UROLOGY devices
- Cook G53740Cook Incorporated · NEEDLE, GASTRO-UROLOGY2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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