SURGIFLO™ Hemostatic Matrix Kit with Thrombin SF2995Recalls & reported problems
Ferrosan Medical Devices A/S · Class 3 · Implant
All models of SURGIFLO Hemostatic Matrix Kit with Thrombin (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15712123000646), received between Jul 30, 2026 and Aug 25, 2026 — classified as 4 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- No Apparent Adverse Event2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Swelling/ Edema2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2026No Apparent Adverse Event
It was reported to the Sales Rep that during a Craniotomy procedure, the surgeon was using Surgiflo when the product became very hard after application. The surgeon stated that the product would normally have a soft, mashed potato-like consistency. No patient consequences were reported. The device is returning.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50427389 ↗InjuryAug 7, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50174071 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
Case 1 of 3:It was reported to the Sales Rep that following a sling procedure, the surgeon used surgical flow intravaginally, and within one week, three patients returned with abscesses. The issue was reported to have occurred in three instances involving three different patients however, no additional information is available for the other patients. No further information was provided. The device is not being returned.
Patient problems: Swelling/ Edema
MAUDE report 50080892 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
Case 2 of 3:It was reported to the Sales Rep that following a sling procedure, the surgeon used surgical flow intravaginally, and within one week, three patients returned with abscesses. The issue was reported to have occurred in three instances involving three different patients however, no additional information is available for the other patients. No further information was provided. The device is not being returned.
Patient problems: Swelling/ Edema
MAUDE report 50080890 ↗
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
- 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 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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