SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1974Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15712123000189), received between May 8, 2019 and Dec 29, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Off-Label Use” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2020Off-Label Use; Off-Label Use

  THIS ADVERSE EVENT COMES FROM AN ARTICLE: LAM, F.C. ET AL., AUGMENTED AUTOLOGOUS PERICRANIUM DURAPLASTY IN 100 POSTERIOR FOSSA SURGERIES - A RETROSPECTIVE CASE SERIES, OPERATIVE NEUROSURGERY, VOLUME 71(2), DECEMBER 2012; 302-307. AUTHORS' BACKGROUND: THE AUTHORS ARE WORKING AT DIVISION OF NEUROSURGERY, BETH ISRAEL DEACONESS MEDICAL CENTER, HARVARD UNIVERSITY, BOSTON, MASSACHUSETTS, US. STUDY DESIGN: THE OBJECTIVE WITH THE CASE SERIES IS FOR THE AUTHORS TO REPORT ON THEIR EXPERIENCE USING LOCALLY HARVESTED AUTOLOGOUS PERICRANIUM AS A DURAL SUBSTITUTE IN PATIENTS WHO UNDERWENT POSTERIOR FOSSA SURGERIES. THIS IS A RETROSPECTIVE CASE SERIES OF 100 PATIENTS WHO UNDERWENT ELECTIVE SUBOCCIPITAL CRANIOTOMY AT THE BETH ISRAEL DEACONESS MEDICAL CENTER IN THE PERIOD FROM JULY 2005 TO DECEMBER 2011. OUT OF THE 100 PATIENTS, THE COMPLICATION RATE WAS 1% WITH 1 PATIENT DEVELOPING A NONSTEROIDAL ANTI-INFLAMMATORY DRUG-INDUCED ASEPTIC MENINGITIS AND GRAFT DEHISCENCE REQUIRING SURGICAL REVISION. THE AUTHORS NOTE ON PAGE 306 ". WE COULD DEMONSTRATE BY ALLERGEN TESTING THAT OUR CASE OF ASEPTIC MENINGITIS WAS DUE TO AN NSAID ALLERGY AND NOT SECONDARY TO REACTION TO THE DURAL SEALANT". OUR REFERENCE QN

  Patient problems: Meningitis; Wound Dehiscence

  MAUDE report 11086749 ↗
• InjuryMay 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY UNDERWENT A CERVICAL THORACIC LAMINECTOMY PROCEDURE ON (B)(6) 2018 AND AN ABSORBABLE HEMOSTAT WAS USED. THE ABSORBABLE HEMOSTAT WAS APPLIED TO THE SPINAL DURA IN TWO LOCATIONS, THE CERVICAL AND THORACIC. THE PROCEDURE WAS COMPLETED AND WHEN THE PATIENT CAME OUT OF THE ANESTHESIA HE FOUND THAT HE WAS PARALYZED. HE WAS TAKEN FROM THE SURGICAL CENTER WHERE THE OPERATION WAS PERFORMED TO AN IN-PATIENT ACUTE SPINAL CORD INJURY REHABILITATION CENTER. HE STAYED THERE FOR SEVERAL MONTHS. FROM THERE HE WAS TAKEN TO A SKILLED NURSING SPINAL CORD INJURY REHABILITATION CENTER. THE PATIENT DID NOT SPECIFY HOW LONG HE STAYED AT THAT FACILITY. FROM THERE HE WAS TAKEN TO A FACILITY FOR OUTPATIENT PHYSICAL THERAPY WHERE HE ENGAGED IN PHYSICAL THERAPY AND OCCUPATIONAL THERAPY FOR NEUROLOGICAL DEFECTS SEVERAL DAYS A WEEK. THE PATIENT'S DOCTOR DEFINED THE PATIENT¿S CONDITION AS TETRA PARESIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Paralysis

  MAUDE report 8592615 ↗

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, Classified
  SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
• Z-1584-2022 · May 25, 2022 · Open, Classified
  Ethicon 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 · Terminated
  ETHICON 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 · Terminated
  ETHICON 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 · Terminated
  Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan