Cook G00012Recalls & reported problems
Cook Incorporated · Chiba Biopsy Needle · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002000124), received between Feb 27, 2017 and Oct 5, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).
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
- Mar 1, 2024Open, Classified
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Z-1525-2024 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Detachment Of Device Component1
- Device Contamination with Chemical or Other Material1
Patient problems
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 5, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING AN PRE-USE INSPECTION OF THE CHIBA BIOPSY NEEDLE, AN UNIDENTIFIED PARTICLE WAS DISCOVERED IN THE PRIMARY PACKAGE. THE CUSTOMER CONFIRMED THAT THE DEVICE NEVER MADE CONTACT WITH ANY PATIENT; ACCORDINGLY, NO ADVERSE EVENTS OCCURRED. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN.
Patient problems: No Patient Involvement
MAUDE report 6918053 ↗MalfunctionFeb 27, 2017Detachment Of Device Component; Detachment Of Device Component
INTERNATIONAL CUSTOMER REPORTED THAT "WHEN YOU PLUGGED THE DEVICE INTO THE 10 ML SYRINGE, THE NEEDLE OF THE DEVICE SHIFTED." NO FURTHER EVENT INFORMATION OR FAILURE MODE DESCRIPTION WAS PROVIDED. THE INTENDED PROCEDURE OR USE OF THE DEVICE WAS NOT PROVIDED. PHOTOGRAPHIC IMAGES OF THE DEVICE INVOLVED WERE PROVIDED AND REVIEWED. THE IMAGE SHOWED A CHIBA BIOPSY NEEDLE SEPARATED FROM THE HUB. NO FURTHER EVENT OR PATIENT RELATED INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6361032 ↗
Other DEVICE, PERCUTANEOUS, BIOPSY devices
- Cook G03314Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G03978Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G01559Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G04338Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G00013Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G00852Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G05040Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G00850Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.