Cook G00996Recalls & reported problems
Cook Incorporated · Dilator · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002009967), received between Oct 11, 2017 and Jul 18, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping2
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22546939 ↗MalfunctionJul 27, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED, THAT PRIOR TO OPENING THE SEALED PACKAGE ON A DILATOR, THE USER NOTICED A HAIR LIKE SUBSTANCE IN THE PACKAGE. THE DEVICE WAS NOT USED AND NO PATIENT CONTACT WAS MADE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15114266 ↗MalfunctionOct 11, 2017Material Frayed; Material Frayed
THE INTERNATIONAL CUSTOMER REPORTED THAT, PRIOR TO THE USE OF THE DILATOR IN A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY, FRAY LIKE DAMAGE WAS NOTED ON THE TIP OF THE DEVICE. THE DEVICE WAS EXCHANGED FOR ANOTHER OF THE SAME LOT TO COMPLETE THE PROCEDURE. THIS ISSUE WAS DISCOVERED PRIOR TO PATIENT CONTACT; ACCORDINGLY, NO PATIENT ADVERSE EVENTS OCCURRED AS A RESULT F THE PRODUCT ISSUE. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN.
Patient problems: No Patient Involvement
MAUDE report 6941621 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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