AviteneRecalls & reported problems across all models
Davol Inc. · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Avitene model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 1
We found 8 models of Avitene by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Jul 12, 2017 and Apr 24, 2026 — classified as 6 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (11 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Avitene recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 25, 2026Class IIOpen, Classified
Potential for product to contain foreign matter, confirmed to be inspect fragments.
Z-1896-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Avitene problems
Device problems
- Device Contamination with Chemical or Other Material11
- Patient-Device Incompatibility5
- Incorrect, Inadequate or Imprecise Result or Readings4
- Tear, Rip or Hole in Device Packaging2
- Material Too Rigid or Stiff1
- Off-Label Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Intervertebral Disc Compression or Protrusion2
- Necrosis2
- No Consequences Or Impact To Patient2
- No Patient Involvement2
- Granuloma1
- Pain1
Avitene models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Avitene 1050030Agent, absorbable hemostatic, collagen based1 recall1 report
- Avitene 1010020Agent, absorbable hemostatic, collagen based7 reports
- Avitene 1010090Agent, absorbable hemostatic, collagen based7 reports
- Avitene 1020010Agent, absorbable hemostatic, collagen based3 reports
- Avitene 1050050Agent, absorbable hemostatic, collagen based2 reports
- Avitene 1010010Agent, absorbable hemostatic, collagen based1 report
- Avitene 1010150Agent, absorbable hemostatic, collagen based1 report
- Avitene 1050040Agent, absorbable hemostatic, collagen based1 report
Recent Avitene adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2026Tear, Rip or Hole in Device Packaging
AS REPORTED, DURING SET UP OF A LAMINECTOMY PROCEDURE, UPON OPENING THE FOIL POUCH OF THE AVITENE FLOWABLE, WRINKLING OF THE FOIL POUCH WAS OBSERVED, AND SMALL HOLES WERE NOTED AT THE WRINKLED AREAS. THERE WAS NO DAMAGE NOTED TO THE OUTER PACKAGING. THIS FILE REPRESENTS DEVICE #2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24983610 ↗MalfunctionApr 24, 2026Tear, Rip or Hole in Device Packaging
AS REPORTED, DURING SET UP OF A LAMINECTOMY PROCEDURE, UPON OPENING THE FOIL POUCH OF THE AVITENE FLOWABLE, WRINKLING OF THE FOIL POUCH WAS OBSERVED, AND SMALL HOLES WERE NOTED AT THE WRINKLED AREAS. THERE WAS NO DAMAGE NOTED TO THE OUTER PACKAGING. THIS FILE REPRESENTS DEVICE #1.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24983586 ↗MalfunctionMar 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
AS REPORTED, DURING POSTERIOR LONGITUDINAL LIGAMENT (PLL) DISSECTION, THE AVITENE FLOWABLE WAS UNSUCCESSFUL IN CONTROLLING THE BLEEDING. THE SURGEON APPLIED FLOWABLE THREE TIMES, AFTER THE THIRD UNSUCCESSFUL ATTEMPT WITH FLOWABLE, THEY USED A NON-BD PRODUCT TO COMPLETE THE PROCEDURE. THIS FAILURE CAUSED A DELAY IN THE PROCEDURE. IT WAS CONFIRMED THAT THE PATIENT WAS NOT HEPARINIZED DURING THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690269 ↗MalfunctionDec 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED, AN AVITENE ULTRAFOAM ALLEGEDLY HAD A FOREIGN MATERIAL (SMALL BROWN COLOR) ON THE SURFACE OF THE PRODUCT IN THE INNER STERILE PACKAGE; DISCOVERED PRIOR TO USE. THE OUTER PACKAGING WAS INTACT, AND THE INNER PACKAGING WAS COMPLETELY SEALED BEFORE OPENING. THE ULTRAFOAM WAS NOT USED AND THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23829294 ↗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 ↗InjuryJun 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
AS REPORTED, THE PATIENT UNDERWENT A PROCEDURE WITH USAGE OF AVITENE, AFTER WHICH A GRANULOMA WAS FOUND. CLEANING WAS PERFORMED AFTER PLACING THE AVITENE AND HEMOSTASIS ACHIEVED. IT WAS REPORTED THAT THE PATIENT IS CURRENTLY BEING TREATED.
Patient problems: Granuloma
MAUDE report 22168198 ↗MalfunctionDec 23, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED, A BLACK FOREIGN OBJECT WAS FOUND IN THE AVITENE IN AN UNOPENED STATE BEFORE USE. IT WAS REPORTED THAT THERE WAS NO SIGN OF PACKAGE DAMAGE FOUND. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21000994 ↗InjuryJun 12, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
PER MEDWATCH REPORT (MW5154685): ON OR ABOUT (B)(6) 2020 A DEPUY SPINAL WAS USED IN PATIENT SURGERY. UPON INFORMATION, THE PRODUCT USED IN PATIENT SURGERY INCLUDE DEPUY EXPEDIUM, COBALT CHROMIUM RODS, UNIAXIAL PEDICEL SCREWS, DEPUY SPINE SCREWS, ROD VIPER STRAIGHT AND OR OTHER ASSOCIATED DEVICES. THE PATIENT HAD SOME PAIN POSTOPERATIVELY AND ALSO HAD DESCRIPTIONS OF CRACKING AND POPPING INVOLVING HER LUMBOSACRAL SPINE. X-RAY REVEALED A DISENGAGEMENT OF THE LEFT-SIDED ROD FROM HER L3 PEDICLE SCREW AND THE PATIENT'S CORONAL BALANCE ALSO APPEARED TO BE SIGNIFICANTLY AFFECTED. PATIENT WAS CAUSED TO SUSTAIN SEVERE, SERIOUS, PERMANENT INJURIES THAT HAD RENDERED HER SICK LORE, LAME AND DISABLED. ALSO NOTED THE PATIENT EXPERIENCED NECROSIS. ON (B)(6) 2020 THE PATIENT UNDERWENT REINSERTION OF SPINAL FIXATION DEVICE WITH REVISION OF INSTRUMENTATION DUE TO POSTERIOR INSTRUMENTED SPINAL FUSION HARDWARE FAILURE. ON (B)(6) 2020 THE PATIENT UNDERWENT EXCISIONAL DEBRIDEMENT OF SKIN INCLUDING THE SUBCUTANEOUS LEVEL AND FASCIA, RIGHT SIDE AND LEFT SIDE. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)." NOTE: THE COMPLAINT REPORTED FAILURE OF SPINAL I
Patient problems: Necrosis
MAUDE report 19520170 ↗InjuryJun 12, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
PER MEDWATCH REPORT (MW5154686): ON OR ABOUT (B)(6) 2020 A DEPUY SPINAL WAS USED IN PATIENT SURGERY. UPON INFORMATION, THE PRODUCT USED IN PATIENT SURGERY INCLUDE DEPUY EXPEDIUM, COBALT CHROMIUM RODS, UNIAXIAL PEDICEL SCREWS, DEPUY SPINE SCREWS, ROD VIPER STRAIGHT AND OR OTHER ASSOCIATED DEVICES. THE PATIENT HAD SOME PAIN POSTOPERATIVELY AND ALSO HAD DESCRIPTIONS OF CRACKING AND POPPING INVOLVING HER LUMBOSACRAL SPINE. X-RAY REVEALED A DISENGAGEMENT OF THE LEFT-SIDED ROD FROM HER L3 PEDICLE SCREW AND THE PATIENT'S CORONAL BALANCE ALSO APPEARED TO BE SIGNIFICANTLY AFFECTED. PATIENT WAS CAUSED TO SUSTAIN SEVERE, SERIOUS, PERMANENT INJURIES THAT HAD RENDERED HER SICK LORE, LAME AND DISABLED. ALSO NOTED THE PATIENT EXPERIENCED NECROSIS. ON (B)(6) 2020 THE PATIENT UNDERWENT REINSERTION OF SPINAL FIXATION DEVICE WITH REVISION OF INSTRUMENTATION DUE TO POSTERIOR INSTRUMENTED SPINAL FUSION HARDWARE FAILURE. ON (B)(6) 2020 THE PATIENT UNDERWENT EXCISIONAL DEBRIDEMENT OF SKIN INCLUDING THE SUBCUTANEOUS LEVEL AND FASCIA, RIGHT SIDE AND LEFT SIDE. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)". REFERENCE REPORT MW5154685. NOTE: THE COMPLAINT
Patient problems: Necrosis
MAUDE report 19520166 ↗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 ↗InjuryDec 8, 2023Off-Label Use; Off-Label Use
AS REPORTED, THE PATIENT UNDERWENT THE ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE ON (B)(6) 2023. AVITENE FLOUR 1 GRAM MIXED WITH SALINE AND THROMBIN WAS USED (OFF LABEL PER IFU). THE SURGEON LEFT EXCESS AVITENE IN AND SEEPED INTO THE EPIDURAL SPACE LEADING TO SPINAL CORD COMPRESSION. POST USAGE PATIENT EXPERIENCED PAIN AND WEAKNESS IN ARM AND UNDERWENT ADDITIONAL SURGERY ON (B)(6) 2023 WHICH INCLUDED A CORPECTOMY. NO OTHER HEMOSTATIC AGENTS OR PRODUCTS WERE USED.
Patient problems: Intervertebral Disc Compression or Protrusion
MAUDE report 18291237 ↗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 ↗MalfunctionSep 6, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED, DURING A PROCEDURE, THE SURGICAL TECH ON THE STERILE FIELD CUT INTO THE AVITENE ULTRAFOAM AND A SHORT BLACK HAIR EMERGED FROM THE INSIDE OF THE FOAM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17690637 ↗MalfunctionAug 10, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
AS REPORTED, THE PHYSICIAN USED AVITENE ULTRAFOAM DURING A PROCEDURE, BUT THE PRODUCT FAILED TO ACHIEVE HEMOSTASIS EFFECTIVELY IN APPLICATION. THE PRODUCT WAS REPORTED TO HAVE MADE CONTACT WITH THE PATIENT BODY FLUIDS. THERE WAS NO HARM TO PATIENT. IT WAS REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH THE SAME PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17498043 ↗
Other Davol Inc. products
All Davol Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page