SURGIFLO® Hemostatic Matrix 2991Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 15712123000318), received between May 6, 2024 and Aug 4, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 reports).

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Post-Op of an Unknown Procedure that the patient experienced a Surgical Site Infection. The site was not irrigated and the indication for use was not met. No product is available for evaluation.Procedure: (b)(6)2026.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50126180 ↗
• InjuryMay 26, 2026Off-Label Use

  (DESCRIPTION FROM THE ARTICLE): COMPLICATIONS: SKULL BASE AND CEREBROVASCULAR WALTER C. JEAN, MD,1,2 FADY T. CHARBEL, MD,3 AARON A. COHEN-GADOL, MD, MSC, MBA,4 WILLIAM T. COULDWELL, MD, PHD,5 MICHAEL T. LAWTON, MD,6 MICHAEL MCDERMOTT, MD,7,8 JACQUES J. MORCOS, MD,9 ROBERT F. SPETZLER, MD,6 AND HARRY R. VAN LOVEREN, MD2 PART 10: CHONDROSARCOMA MULTIPLE COMPLICATIONS. OBJECTIVE: THE PATIENT WAS A YOUNG WOMAN FOUND TO HAVE AN EXPANSILE LESION OF THE RIGHT PETROUS BONE. HER COMPLAINTS INCLUDED MIGRAINE HEADACHES WITH NAUSEA AND PHOTOPHOBIA, INTERMITTENT RINGING IN THE RIGHT EAR, AND RIGHT AURAL FULLNESS WITH DIFFICULTY "POPPING HER EAR." SHE HAD ALSO HAD SEVERAL MINOR EAR INFECTIONS. HER AUDIOGRAM WAS NORMAL. IMAGING REVEALED A MASS IN HER RIGHT PETROUS BONE, BUT THE PATIENT WAS DEEMED ASYMPTOMATIC FROM THIS LESION. SHE PRESENTED TO THE NEUROSURGERY DEPARTMENT AT 2 MONTHS POSTPARTUM, AND HER PRIMARY DESIRE WAS TO BOND WITH HER NEW BABY. THE PRESUMPTIVE DIAGNOSIS WAS CHONDROSARCOMA, AND SURVEILLANCE WAS THE RECOMMENDATION. SHE REMAINED STABLE FOR 2 YEARS, BUT AT THE 3-YEAR SURVEILLANCE MARK THE TUMOR HAD SLIGHTLY INCREASED IN SIZE. AXIAL IMAGES SHOWED A TUMOR SIZE OF 2.6 × 1.8 CM (PREVI

  Patient problems: Embolism/Embolus

  MAUDE report 25274871 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OP OF A HYSTERECTOMY PROCEDURE THAT THE PATIENT EXPERIENCED A SURGICAL SITE INFECTION. THE SITE WAS NOT IRRIGATED AND THERE WAS NO EXCESS BLEEDING IMMEDIATELY PRIOR TO HEMOSTATIC AGENT APPLICATION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 25274702 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OP OF A HYSTERECTOMY PROCEDURE THAT THE PATIENT EXPERIENCED A SURGICAL SITE INFECTION. THE SITE WAS NOT IRRIGATED AND THERE WAS NO EXCESS BLEEDING IMMEDIATELY PRIOR TO HEMOSTATIC AGENT APPLICATION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 25274701 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OP OF AN UNKNOWN INPATIENT PROCEDURE THAT THE PATIENT EXPERIENCED A SURGICAL SITE INFECTION. NO ADHESION BARRIER WAS USED AND THE SITE WAS NOT IRRIGATED. NO DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 25274700 ↗
• InjuryMay 6, 2025Off-Label Use; Off-Label Use

  IT WAS REPORTED BY THE SURGEON THAT THEY ARE AN INTERVENTIONAL RADIOLOGIST AND HAVE BEEN USING SURGIFLO TO OCCLUDE BIOPSY TRACTS. THEY HAVE HAD MORE HEMATOMAS THEN THEY WOULD EXPECT AFTER KIDNEY BIOPSIES.

  Patient problems: Hematoma

  MAUDE report 21966152 ↗
• InjuryMay 6, 2025Off-Label Use; Off-Label Use

  IT WAS REPORTED BY THE SURGEON THAT THEY ARE AN INTERVENTIONAL RADIOLOGIST AND HAVE BEEN USING SURGIFLO TO OCCLUDE BIOPSY TRACTS. THEY HAVE HAD MORE HEMATOMAS THEN THEY WOULD EXPECT AFTER KIDNEY BIOPSIES.

  Patient problems: Hematoma

  MAUDE report 21966036 ↗
• InjurySep 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON AN UNKNOWN DATE AND SURGIFLO WAS PLACED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20277106 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. IT WAS REPORTED THAT THE PATIENT IS EXPERIENCED AN UNKNOWN ADVERSE EVENT. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Insufficient Information

  MAUDE report 20130377 ↗
• InjuryAug 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP, THAT DURING POST-OP FOR A PROSTATECTOMY, THAT THERE HAS BEEN AN UNKNOWN AMOUNT OF PATIENTS THAT HAVE BECOME SEPTIC POST-OP. THEY HAVE BEEN USING THE PRODUCT 2991 TO FILL IN THE DEAD SPACE AFTER THEY BRING DOWN THE BLADDER NECK. THEY HAVE NOT HAD THIS ISSUE BEFORE AND THINK THE SURGIFLO COULD BE CAUSING IT. THEY ARE CURRENTLY USING SURGIFLO WITH SALINE AND NOT THROMBIN. NO PATIENT CONSEQUENCE. DEVICE IS NOT AVAILABLE. SALES REP CALLED BACK WITH A LITTLE MORE INFORMATION. HE IS STILL WORKING ON GETTING ANSWERS TO THE QUESTIONS IN THE FOLLOW-UP NOTE. HE STATED THAT THERE ARE FOUR SEPTIC PATIENTS THAT HAVE BEEN REPORTED IN THE LAST TWO TO THREE WEEKS. THEY NOTICE THAT THE PATIENTS BECOME SEPTIC RIGHT AFTER THE REMOVE THE CATHETER. THE MINUTE THEY REMOVE THE CATHETER THEY HAVE BECOME SEPTIC. THE FACILITY HAS NOT CHANGED ANYTHING REGARDING THEIR PROCEDURE OTHER THAN ADDING IN THE USE OF SURGIFLO. I RECENTLY HAD DISCUSSIONS WITH AN UROLOGY SURGEON AT X HOSPITAL WHERE THEY HAVE BEEN USING SURGIFLO (2991) WITH SALINE FOR THEIR PROSTATECTOMY'S AND RECENTLY HAVE HAD 4 PATIENTS WHO HAVE GONE SEPTIC OVER THE PAST COUPLE WEEKS. I HAVE SPOKEN WITH THE FIRST ASSIS

  Patient problems: Sepsis

  MAUDE report 19990484 ↗
• InjuryAug 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP, THAT DURING POST-OP FOR A PROSTATECTOMY, THAT THERE HAS BEEN AN UNKNOWN AMOUNT OF PATIENTS THAT HAVE BECOME SEPTIC POST-OP. THEY HAVE BEEN USING THE PRODUCT 2991 TO FILL IN THE DEAD SPACE AFTER THEY BRING DOWN THE BLADDER NECK. THEY HAVE NOT HAD THIS ISSUE BEFORE AND THINK THE SURGIFLO COULD BE CAUSING IT. THEY ARE CURRENTLY USING SURGIFLO WITH SALINE AND NOT THROMBIN. NO PATIENT CONSEQUENCE. DEVICE IS NOT AVAILABLE. SALES REP CALLED BACK WITH A LITTLE MORE INFORMATION. HE IS STILL WORKING ON GETTING ANSWERS TO THE QUESTIONS IN THE FOLLOW-UP NOTE. HE STATED THAT THERE ARE FOUR SEPTIC PATIENTS THAT HAVE BEEN REPORTED IN THE LAST TWO TO THREE WEEKS. THEY NOTICE THAT THE PATIENTS BECOME SEPTIC RIGHT AFTER THE REMOVE THE CATHETER. THE MINUTE THEY REMOVE THE CATHETER THEY HAVE BECOME SEPTIC. THE FACILITY HAS NOT CHANGED ANYTHING REGARDING THEIR PROCEDURE OTHER THAN ADDING IN THE USE OF SURGIFLO. I RECENTLY HAD DISCUSSIONS WITH AN UROLOGY SURGEON AT X HOSPITAL WHERE THEY HAVE BEEN USING SURGIFLO (2991) WITH SALINE FOR THEIR PROSTATECTOMY'S AND RECENTLY HAVE HAD 4 PATIENTS WHO HAVE GONE SEPTIC OVER THE PAST COUPLE WEEKS. I HAVE SPOKEN WITH THE FIRST ASSIS

  Patient problems: Sepsis

  MAUDE report 19990244 ↗
• InjuryAug 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP, THAT DURING POST-OP FOR A PROSTATECTOMY, THAT THERE HAS BEEN AN UNKNOWN AMOUNT OF PATIENTS THAT HAVE BECOME SEPTIC POST-OP. THEY HAVE BEEN USING THE PRODUCT 2991 TO FILL IN THE DEAD SPACE AFTER THEY BRING DOWN THE BLADDER NECK. THEY HAVE NOT HAD THIS ISSUE BEFORE AND THINK THE SURGIFLO COULD BE CAUSING IT. THEY ARE CURRENTLY USING SURGIFLO WITH SALINE AND NOT THROMBIN. NO PATIENT CONSEQUENCE. DEVICE IS NOT AVAILABLE. SALES REP CALLED BACK WITH A LITTLE MORE INFORMATION. HE IS STILL WORKING ON GETTING ANSWERS TO THE QUESTIONS IN THE FOLLOW-UP NOTE. HE STATED THAT THERE ARE FOUR SEPTIC PATIENTS THAT HAVE BEEN REPORTED IN THE LAST TWO TO THREE WEEKS. THEY NOTICE THAT THE PATIENTS BECOME SEPTIC RIGHT AFTER THE REMOVE THE CATHETER. THE MINUTE THEY REMOVE THE CATHETER THEY HAVE BECOME SEPTIC. THE FACILITY HAS NOT CHANGED ANYTHING REGARDING THEIR PROCEDURE OTHER THAN ADDING IN THE USE OF SURGIFLO. I RECENTLY HAD DISCUSSIONS WITH AN UROLOGY SURGEON AT X HOSPITAL WHERE THEY HAVE BEEN USING SURGIFLO (2991) WITH SALINE FOR THEIR PROSTATECTOMY'S AND RECENTLY HAVE HAD 4 PATIENTS WHO HAVE GONE SEPTIC OVER THE PAST COUPLE WEEKS. I HAVE SPOKEN WITH THE FIRST ASSIS

  Patient problems: Sepsis

  MAUDE report 19989865 ↗
• InjuryAug 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP, THAT AROUND TWO TO THREE MONTHS POST-OP FOR A PROSTATECTOMY, THAT THERE HAS BEEN AN UNKNOWN AMOUNT OF PATIENTS THAT HAVE HAD CALCIFICATION AROUND THE SITE WHERE THEY USED THE SURGIFLO. THEY HAVE BEEN USING THE PRODUCT 2991 TO FILL IN THE DEAD SPACE AFTER THEY BRING DOWN THE BLADDER NECK. THEY HAVE NOT HAD THIS ISSUE BEFORE AND THINK THE SURGIFLO COULD BE CAUSING IT. THEY ARE CURRENTLY USING SURGIFLO WITH SALINE AND NOT THROMBIN. NO PATIENT CONSEQUENCE. DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 19989723 ↗
• InjuryAug 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP, THAT DURING POST-OP FOR A PROSTATECTOMY, THAT THERE HAS BEEN AN UNKNOWN AMOUNT OF PATIENTS THAT HAVE BECOME SEPTIC POST-OP. THEY HAVE BEEN USING THE PRODUCT 2991 TO FILL IN THE DEAD SPACE AFTER THEY BRING DOWN THE BLADDER NECK. THEY HAVE NOT HAD THIS ISSUE BEFORE AND THINK THE SURGIFLO COULD BE CAUSING IT. THEY ARE CURRENTLY USING SURGIFLO WITH SALINE AND NOT THROMBIN. NO PATIENT CONSEQUENCE. DEVICE IS NOT AVAILABLE. SALES REP CALLED BACK WITH A LITTLE MORE INFORMATION. HE IS STILL WORKING ON GETTING ANSWERS TO THE QUESTIONS IN THE FOLLOW-UP NOTE. HE STATED THAT THERE ARE FOUR SEPTIC PATIENTS THAT HAVE BEEN REPORTED IN THE LAST TWO TO THREE WEEKS. THEY NOTICE THAT THE PATIENTS BECOME SEPTIC RIGHT AFTER THE REMOVE THE CATHETER. THE MINUTE THEY REMOVE THE CATHETER THEY HAVE BECOME SEPTIC. THE FACILITY HAS NOT CHANGED ANYTHING REGARDING THEIR PROCEDURE OTHER THAN ADDING IN THE USE OF SURGIFLO. I RECENTLY HAD DISCUSSIONS WITH AN UROLOGY SURGEON AT X HOSPITAL WHERE THEY HAVE BEEN USING SURGIFLO (2991) WITH SALINE FOR THEIR PROSTATECTOMY'S AND RECENTLY HAVE HAD 4 PATIENTS WHO HAVE GONE SEPTIC OVER THE PAST COUPLE WEEKS. I HAVE SPOKEN WITH THE FIRST ASSIS

  Patient problems: Sepsis

  MAUDE report 19989700 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER USER FACILITY MEDWATCH FORM #MW5153569 AND MW5153570, DURING AN UNKNOWN PROCEDURE, THERE WAS VAGINAL CUFF DEHISCENCE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. PROCEDURE DATE: (B)(6) 2024. EVENT DATE: 01/03/2024.

  Patient problems: Wound Dehiscence

  MAUDE report 19248548 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER USER FACILITY MEDWATCH FORM #MW5153563, THE PATIENT EXPERIENCED VAGINAL CUFF DEHISCENCE. THE DEVICE WAS AVAILABLE FOR RETURN. EVENT DATE: (B)(6) 2024

  Patient problems: Wound Dehiscence

  MAUDE report 19248504 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER USER FACILITY MEDWATCH FORM #MW5153569 AND MW5153570*, DURING AN UNKNOWN PROCEDURE, THERE WAS VAGINAL CUFF DEHISCENCE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. PROCEDURE DATE: (B)(6) 2024 EVENT DATE: (B)(6) 2024

  Patient problems: Wound Dehiscence

  MAUDE report 19248401 ↗

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