Avitene 1010150Recalls & reported problems
Davol Inc. · EndoAvitene Microfibrillar Collagen Hemostat in an Endoscopic Delivery System · Class 3 · Implant
All models of Avitene (8)
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 00801741010484), received between Sep 25, 2018 and Sep 25, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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
- Incorrect, Inadequate or Imprecise Result or Readings1
- Material Too Rigid or Stiff1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2018Incorrect, Inadequate or Imprecise Result or Readings; Material Too Rigid or Stiff; Incorrect, Inadequate or Imprecise Result or Readings; Material Too Rigid or Stiff
IT WAS REPORTED BY THE USER FACILITY THAT THE AVITENE HEMOSTAT DID NOT COME OUT POWDERY AS WAS ANTICIPATED, BUT INSTEAD "LIKE A BLOCK OF CEMENT". THE AVITENE APPLIED WOULD NOT INTEGRATE PROPERLY AND DID NOT REDUCE THE BLOOD FLOW. ANOTHER HEMOSTAT, ARISTA WAS APPLIED TO THE SITE AND WORKED APPROPRIATELY. THERE WAS NO PATIENT INJURY THAT PRESENTED AS A RESULT OF THE REPORTED PROBLEM WITH THE AVITENE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7905210 ↗
Other Agent, absorbable hemostatic, collagen based devices
- SURGIFLO® Hemostatic Matrix Kit with Thrombin 2994Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 recall42 reports
- SURGIFOAM® Absorbable Gelatin Powder Kit 1979Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 recall2 reports
- Avitene 1050030Davol Inc. · Agent, absorbable hemostatic, collagen based1 recall1 report
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1972Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based24 reports
- SURGIFLO® Hemostatic Matrix 2991Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based17 reports
- 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 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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