SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1973Recalls & reported problems
Ferrosan Medical Devices A/S · Class 3 · Implant
All models of SURGIFOAM Absorbable Gelatin Sponge, U.S.P. (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15712123000172), received between Dec 29, 2020 and Dec 29, 2020 — classified as 1 death.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
5 other recalls cover devices cleared under the same FDA submission (P990004); they may or may not involve this specific model.
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 18, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Thromboembolism1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathDec 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE AND SURGIFOAM WAS USED. A PIECE OF THE SURGIFOAM BECAME LODGED AND MOVED THROUGH THE PATIENT'S INTERNAL MAMMARY ARTERY NEAR THE STERNUM, THEN INTO THE VERTEBRAL AND SUBLCLAVIAN ARTERIES CAUSING THE BASILAR ARTERY OCCLUSION AND THE PATIENT TO HAVE A STROKE. A CTA OF THE NECK AND BRAIN SHOWED THE RVA OCCLUSION. FERROSAN MEDICAL DEVICES (B)(4) REFERENCE NO.: (B)(4). THIS EVENT WAS ORIGINALLY REPORTED AS 3008478369-2018-00003. HOWEVER, A MAUDE SEARCH SHOWED THAT THIS REPORT NUMBER WAS INADVERTENTLY OVERWRITTEN BY THE IMPORTER.
Patient problems: Thromboembolism
MAUDE report 11086468 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P990004. One submission often covers many models, so check the product and lot details in each record.
- Z-1881-2024 · Apr 23, 2024 · Open, ClassifiedSURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
- Z-1584-2022 · May 25, 2022 · Open, ClassifiedEthicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 Mfg: FERROSAN MEDICAL DEVICES A/S Indicated in surgical procedures (other than ophthalmic) as an adjunct
- Z-0293-2013 · Aug 21, 2012 · TerminatedETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a topical absorbable hemostat consisting of a flo
- Z-0292-2013 · Aug 21, 2012 · TerminatedETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 SURGIFLO Hemostatic Matrix, mixed wit
- Z-1897-2012 · Apr 3, 2012 · TerminatedEthicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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