Avitene 1020010Recalls & reported problems
Davol Inc. · Avitene Flowable Collagen Hemostat, 10 ml · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741223105), received between Mar 25, 2026 and Apr 24, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (2 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
- Tear, Rip or Hole in Device Packaging2
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, 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 ↗
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 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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