Cook G09664Recalls & reported problems
Cook Incorporated · Polyvinyl Alcohol (PVA) Foam Particles · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00827002096646), received between Dec 15, 2018 and Dec 15, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Discolored” (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 16, 2026.
Most reported problems
Device problems
- Material Discolored1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2018Material Discolored
THE COMPLAINANT REPORTED THAT THE PVA FOAM EMBOLIZATION PARTICLES TURNED RED WHILE "TURNING ON THE VIAL". PART OF THE PRODUCT(S) HAD BEEN USED ON THE PATIENT FOR THE TACE (TRANSCATHETER ARTERIAL EMBOLIZATION) PROCEDURE IN THE LIVER. THE CAUSE FOR THE RED PARTICLES COULD NOT BE DETERMINED WITH CERTAINTY, AND THIS PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8167550 ↗
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- Embosphere® 00884450106051Biosphere Medical · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS3 reports
- Embosphere® 00884450116296Biosphere Medical · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS1 report
- Cook G09665Cook Incorporated · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS1 report
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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