Avitene 1010090Recalls & reported problems
Davol Inc. · Avitene Non-Woven Web, 70 mm x 35 mm x 1 mm · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741010460), received between Jul 30, 2019 and Sep 19, 2025 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (6 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material6
- Patient-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Patient Involvement2
- Intervertebral Disc Compression or Protrusion1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED, A BLACK SPOT WAS FOUND IN THE AVITENE PRODUCT DURING ATTEMPTED USE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23096155 ↗MalfunctionFeb 20, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED, A HAIR WAS FOUND IN AVITENE BEFORE USE. IT WAS REPORTED THAT THERE WAS DAMAGE NOTED ON THE OUTER PACKAGE AND A NEW ONE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18739975 ↗MalfunctionNov 21, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED, THE AVITENE HEMOSTAT WAS USED DURING A SURGICAL PROCEDURE. AFTER APPLYING AVITENE TO THE SITE, IT WAS OBSERVED THAT A FOREIGN MATERIAL WAS PRESENT, IMMEDIATELY REMOVED AND ANOTHER AVITENE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, "THE FOREIGN MATERIAL APPEARED TO BE A PIECE OF THE AVITENE PACKAGING" AND NO DAMAGE ON THE OUTER PACKAGE WAS NOTED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18187351 ↗MalfunctionSep 13, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED, DURING AN UNKNOWN PROCEDURE, FOREIGN MATERIAL LIKE HAIR WAS FOUND WHILE OPENING THE PACKAGE OF AVITENE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17736330 ↗InjurySep 16, 2021Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2021 THE BARD/DAVOL AVITENE SHEET WAS USED ON AN EPIDURAL BLEEDING. RESUMPTION OF THE PATIENT BECAUSE OF HARDENING OF THE DEVICE CAUSING SPINAL COMPRESSION. ADDENDUM: IT WAS REPORTED THAT THE BARD/DAVOL AVITENE SHEET WAS APPLIED IN DRY PATCHES IN THE EPIDURAL REGION DURING AN OPEN LUMBAR LAMINECTOMY PROCEDURE ASSOCIATED WITH A HERNIATED DISC EXCISION. AS REPORTED, EXCESS MATERIAL WAS REMOVED BUT SOME REMAINED AROUND THE ROOTS TO PROVIDE HEMOSTASIS AND DID NOT COMPRESS WHEN CLOSING. AS REPORTED, THE PATIENT'S DEFICIT SYMPTOMS DID NOT APPEAR UNTIL SEVERAL HOURS AFTER SURGERY AND ON (B)(6) 2021, THE PATIENT UNDERWENT URGENT SURGERY TO ASPIRATE ALL THE HEMOSTATIC MATERIAL. AS REPORTED, THE PATIENT IS STILL DEFICIENT ON THE LOWER LIMB. THE SURGEON IS A NEW USER OF THE DEVICE.
Patient problems: Intervertebral Disc Compression or Protrusion
MAUDE report 12484922 ↗MalfunctionApr 28, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A FIBER WAS CAUGHT BETWEEN THE TYVEK LID AND TRAY OF THE AVITENE PRODUCT. ANOTHER AVITENE PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Patient Involvement
MAUDE report 10004879 ↗MalfunctionJul 30, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A FIBER WAS CAUGHT BETWEEN THE TYVEK LID AND THE TRAY OF THE AVITENE PRODUCT PACKAGE. THIS WAS NOTED PRIOR TO USE IN THE CASE. THE DEVICE WAS RETURNED FOR EVALUATION.
Patient problems: No Patient Involvement
MAUDE report 8843535 ↗
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 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
- Avitene 1020010Davol Inc. · Agent, absorbable hemostatic, collagen based3 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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