Cook G10207Recalls & reported problems
Cook Incorporated · Dilator With AQ, Hydrophilic Coating · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002102071), received between Feb 19, 2018 and Feb 19, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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-1531-2024 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE INTERNATIONAL CUSTOMER REPORTED THAT, UPON OPENING THE AQ HYDROPHILIC COATED DILATOR, AN UNKNOWN POWDER WAS DISCOVERED ON THE PRODUCT. AS A RESULT, THE DEVICE WAS SUBSEQUENTLY NOT USED DURING THE INSERTION OF THE NEPHROSTOMY CATHETER PROCEDURE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT CONTACT; ACCORDINGLY NO PATIENT ADVERSE EVENTS RESULTED FROM THE PRODUCT PROBLEM. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION, BUT THE INVESTIGATION IS STILL PENDING AS OF THE DATE OF THIS REPORT.
Patient problems: No Patient Involvement
MAUDE report 7280468 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.