Avitene 1010010Recalls & reported problems
Davol Inc. · Avitene Flour, 0.5 gram · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741010439), received between Dec 15, 2022 and Dec 15, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Patient-Device Incompatibility1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 15, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
AS REPORTED, DURING A PERCUTANEOUS LIVER BIOPSY PROCEDURE, BARD/DAVOL AVITENE FLOUR HEMOSTAT WAS USED TO STOP BLEEDING. AS REPORTED, THE PATIENT EXPERIENCED PAIN FOR ONE HOUR POST APPLICATION OF AVITENE AND REQUIRED ANALGESICS TO TREAT THE PAIN.
Patient problems: Pain
MAUDE report 15988426 ↗
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- Avitene 1010090Davol Inc. · Agent, absorbable hemostatic, collagen based7 reports
- Avitene 1010020Davol Inc. · Agent, absorbable hemostatic, collagen based7 reports
- SURGIFLO™ Hemostatic Matrix Kit with Thrombin SF2995Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based4 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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