SURGIFLO® Hemostatic Matrix Kit with Thrombin 2994Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 15712123000288), received between Mar 5, 2021 and Sep 14, 2026 — classified as 39 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (12 reports).

1 FDA recall record name this device's identifier, 1 still open.

4 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.

Recalls naming this device

1. May 25, 2022Class IIOpen, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1584-2022 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Device Handling Problem

  It was reported by the account contact to sales rep that during a crania procedure, an expired device was used during the case. No additional information.No product is available for evaluation. Additional information was received 31.08.2026 stating:Was the use of expired product intentionally? No.Was the expiry date clear readable on the device? Unknown.Why was a expired product used? I was told it was a complete accident by the OR staff.What is the lot number? Unknown.What was the date of the procedure? Unknown.What was the indication for using the product? I was previously told it was for Hemostasis.Was there any patient consequence? Unknown.Can specific patient demographics Initials / ID; Age or date of birth; BMI; gender; patient pre-existing medical conditions (i.e. Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates of study drugs be provided? Unknown.What is the current condition of the patient? Unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50750158 ↗
• InjuryJun 16, 2026Off-Label Use

  CASE 1 OF 3: IT WAS REPORTED THAT GYN SURGEON USES SURGIFLO ON THE VAGINAL CUFF. HE HAS HAD 3 SSIS SINCE CONVERTING FROM FLOSEAL TO SURGIFLO IN (B)(6). HE THINKS SURGIFLO MIGHT BE GIVING HIS PATIENT'S SSIS. NO SURGICAL DELAY WAS REPORTED. PROCEDURE: (B)(6) 2025, EVENT: 11/03/2025 PROCEDURE: GYN. ADDITIONAL INFORMATION WAS RECEIVED ON 28.05.2026 STATING: WHAT IS THE NAME OF EACH PROCEDURE? ALL 3 REPORTS WERE FROM TOTAL HYSTERECTOMIES WHAT WAS THE DATE OF EACH PROCEDURE? PATIENT 1: (B)(6) 2025 PATIENT 2: (B)(6) 2025 PATIENT 3: (B)(6) 2025. ON WHAT DATE DID EACH INFECTION OCCUR? PATIENT 1: (B)(6) 2025 PATIENT 2: (B)(6) 2025 PATIENT 3: (B)(6) 2025. HOW MUCH SURGIFLO WAS USED DURING EACH PROCEDURE? ONE UNIT OF 2994 WAS USED PER PATIENT/CASE. WAS SURGIFLO REMOVED AFTER HEMOSTASIS WAS ACHIEVED? SURGIFLO WAS NOT REMOVED AFTER HEMOSTASIS ON ANY OF THE 3 PATIENTS. WHAT WAS THE INDICATION FOR THE USE OF SURGIFLO? HEMOSTASIS AFTER THE VAGINAL CUFF WAS CLOSED. WHAT WAS THE INDICATION FOR SURGERY? REMOVAL OF THE UTERUS AND CERVIX FOR ALL 3 PATIENTS. WHAT WAS THE MEDICAL HISTORY OF EACH PATIENT? PATIENT 1: UTERINE FIBROIDS PATIENT 2: ENDOMETRIOSIS PATIENT 3: ADENOMYOSIS. WHAT WAS THE TREATMENT FO

  Patient problems: Post Operative Wound Infection

  MAUDE report 25515426 ↗
• InjuryDec 15, 2025Device Handling Problem; Device Handling Problem

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT A SURGIFLO WITH AN EXPIRATION DATE OF NOVEMBER 30, 2025, WAS USED ON A PATIENT, DURING A CAROTID ENDARTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO PRODUCT IS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23800684 ↗
• InjuryNov 24, 2025Device Handling Problem; Device Handling Problem

  EVENT DESCRIPTION: THE SALES REPRESENTATIVE REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE SURGIFLO WAS USED, SOME OF THE PATIENT'S BLOOD WAS SALVAGED AND PROCESSED THROUGH A CELL SAVER, AND THE PROCESSED BLOOD WAS RETURNED TO THE PATIENT. THE DEVICE IS NOT AVAILABLE FOR RETURN. NOTE IN FILE: AS PER REP: "THE SURGICAL TEAM WAS CONCERNED THAT THE BLOOD MAY BE CONTAMINATED WITH THE PARTICLES OF SURGIFLO CELL SAVER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630787 ↗
• InjuryJun 4, 2025Device Handling Problem; Device Handling Problem

  IT WAS REPORTED BY THE SALES REP THAT THE PRODUCT WAS EXPIRED BY ONE DAY AND WAS STILL USED. IT WAS USED MAY 1 BUT EXPIRED ON APRIL 30. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140243 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON HAS STOPPED USING SURGIFLO DUE TO TWO PATIENTS NEEDING TO BE BROUGHT BACK TO THE OR TO CLEAN AND WASHOUT THE INCISION SITE. PATIENTS CURRENTLY DOING FINE. SURGEON HAS SEEN NO MORE ISSUES SINCE STOPPING THE USE OF SURGIFLO ON EVERY PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21354605 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON HAS STOPPED USING SURGIFLO DUE TO TWO PATIENTS NEEDING TO BE BROUGHT BACK TO THE OR TO CLEAN AND WASHOUT THE INCISION SITE. PATIENTS CURRENTLY DOING FINE. SURGEON HAS SEEN NO MORE ISSUES SINCE STOPPING THE USE OF SURGIFLO ON EVERY PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21354492 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROIDECTOMY PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THE SURGEON HAS STOPPED USING THE DEVICE DUE TO TWO PATIENTS NEEDING TO BE BROUGHT BACK TO THE OPERATING ROOM TO CLEAN AND WASHOUT THE INCISION SITE. THE PATIENTS ARE CURRENTLY DOING FINE. SURGEON HAS SEEN NO MORE ISSUES SINCE STOPPING THE USE OF SURGIFLO ON EVERY PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21240158 ↗
• InjuryJan 23, 2025Adverse 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 AN ABSORBABLE HEMOSTAT WAS USED. THE SURGEON HAS STOPPED USING ABSORBABLE HEMOSTAT DUE TO TWO PATIENTS NEEDING TO BE BROUGHT BACK TO THE OPERATING ROOM TO CLEAN AND WASHOUT THE INCISION SITE. PATIENTS CURRENTLY DOING FINE. SURGEON HAS SEEN NO MORE ISSUES SINCE STOPPING THE USE OF ABSORBABLE HEMOSTAT ON EVERY PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21223843 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO THE SALES REP BY THE OPERATING ROOM MANAGER REPORTED ON BEHALF OF THE SURGEON AND HIS PA (B)(6). THAT THEY ARE FRUSTRATED WITH SURGIFLO. THEY PREFER FLOSEAL OVER SURGIFLO. THEY BELIEVE FLOSEAL IS MUCH MORE GRANULAR AND STICKS/ADHERES TO THE TISSUES OF THE BLEEDING SITE. WHERE THEY HAVE NOTICED THAT SURGIFLO ISN'T ADHERING AS WELL AS FLOSEAL EVEN AFTER THEY WAIT 3 MINUTES. THEY ARE STILL NOTICING BLEEDING AT THE BLEEDING SITE. THERE HAVE BEEN TWO PATIENTS THAT HAVE COME BACK WITH HEMATOMAS WHICH WERE ABLE TO BE TREATED WITH MEDICATION BUT (B)(6) THE PA BELIEVES THIS IS DUE TO THE CHANGE TO SURGIFLO OVER FLOSEAL. NO PATIENT CONSEQUENCE WAS REPORTED. NO DEVICE IS AVAILABLE FOR EVALUATION. FOLLOW-UP INFORMATION WAS RECEIVED STATING: WAS SURGIFLO REMOVED AFTER HEMOSTASIS WAS ACHIEVED OR LEFT: "YES, SURGIFLO WAS REMOVED". HOW MUCH SURGIFLO WAS USED?: "1 EACH OF 2994 (8ML)". HOW WAS THE HEMATOMA/S TREATED?: "MEDICATION - NO ADDITIONAL INFORMATION PROVIDED."

  Patient problems: Hematoma

  MAUDE report 20705987 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO THE SALES REP BY THE OR MANAGER REPORTED ON BEHALF OF THE SURGEON AND HIS PA IGOR. THAT THEY ARE FRUSTRATED WITH SURGIFLO. THEY PREFER FLOSEAL OVER SURGIFLO. THEY BELIEVE FLOSEAL IS MUCH MORE GRANULAR AND STICKS/ADHERES TO THE TISSUES OF THE BLEEDING SITE. WHERE THEY HAVE NOTICED THAT SURGIFLO ISN'T ADHEREING AS WELL AS FLOSEAL EVEN AFTER THEY WAIT 3 MINUTES. THEY ARE STILL NOTICING BLEEDING AT THE BLEEDING SITE. THERE HAVE BEEN TWO PATIENTS THAT HAVE COME BACK WITH HEMATOMAS WHICH WERE ABLE TO BE TREATED WITH MEDICATION BUT IGOR THE PA BELIEVES THIS IS DUE TO THE CHANGE TO SURGIFLO OVER FLOSEAL. NO PATIENT CONSEQUENCE WAS REPORTED. NO DEVICE IS AVAILABLE FOR EVALUATION. FOLLOW-UP INFORMATION WAS RECEIVED STATING: - WAS SURGIFLO REMOVED AFTER HEMOSTASIS WAS ACHIEVED OR LEFT: "YES, SURGIFLO WAS REMOVED" - HOW MUCH SURGIFLO WAS USED? "1 EACH OF 2994 (8ML)" - HOW WAS THE HEMATOMA/S TREATED? "MEDICATION - NO ADDITIONAL INFORMATION PROVIDED."

  Patient problems: Hematoma

  MAUDE report 20705818 ↗
• InjuryOct 14, 2024Device Handling Problem; Device Handling Problem

  IT WAS REPORTED BY THE CUSTOMER THAT DURING A LAPAROSCOPIC HERNIA REPAIR WITH MESH, THEY USED THE SURGIFLO WITH THROMBIN. THEY USED THE PRODUCT EVEN THOUGH PRODUCT HAD EXPIRED AUGUST 08/31/2024, DISCUSSED THE PROS AND CONS AND DECIDED TO GO AHEAD AND USE THE EXPIRED PRODUCT. CASE WAS COMPLETED. NO PATIENT HARM. NO PRODUCT WILL BE RETURNED. PROCEDURE DATE: ON (B)(6) 2024. ADDITIONAL INFORMATION HAS BEEN RECEIVED ON 10.10.2024 STATING: PLEASE ELABORATE ON WHY THE EXPIRED DEVICE WASN'T DISCARDED AND A NEW RETRIEVED.:"THERE WAS NO UNEXPIRED SURGIFLO IN THE FACILITY AND THE CASE WAS UNDERWAY." PLEASE CONFIRM THAT THE PATIENT THAT RECEIVED THE EXPIRED PRODUCT DID NOT EXPERIENCE ANY ADVERSE EVENTS BECAUSE OF THE USE: "NONE REPORTED." DID THE EXPIRED PRODUCT ACHIEVE HEMOSTASIS? "YES." WAS SURGIFLO REMOVED AFTER HEMOSTASIS WAS ACHIEVED? "NO. THE BLEEDING WAS UNDER AN IMPLANTABLE MESH THAT HAD ALREADY BEEN TACKED IN PLACE. THE SURGIFLO WAS APPLIED TO THE MESH AND IT PENETRATED THROUGH THE TRELLIS OF THE MESH DIRECTLY ONTO THE BLEEDING SITE. IT WAS LEFT IN PLACE." CAN SPECIFIC PATIENT DEMOGRAPHICS INITIALS/ ID; AGE OR DATE OF BIRTH; BMI; GENDER; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438469 ↗
• MalfunctionAug 5, 2024Defective Component; Defective Component

  IT WAS REPORTED BY THE ACCOUNT CONTACT THAT DURING A C-SECTION PROCEDURE THAT WHILE MIXING THE STERILE "WATER" WAS LEAKING OUT OF THE TOP NEEDING MORE STERILE "WATER" TO BE ADDED. THE PRODUCT WAS USED ON THE PATIENT AND ONCE HANDED BACK TO THE SURGICAL TECH IT WAS FOUND THAT THERE WAS A CHIP GLASS ALONG THE RIM OF THE VIAL. THE SURGEON WAS INFORMED BUT THE PRODUCT HAD ALREADY BEEN USED ON THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO DEVICE RETURNING FOR EVALUATION. THE NURSE REQUEST A VIAL OF STERILE WATER PULLED FROM THE PYXIS AND PULLED THE EXTRA WATER NEEDED FROM THAT TO ADD TO FINISH MIXING. THE CHIP WAS ON THE THROMBIN VIAL IS SELF AROUND THE EDGE WHERE THE METAL RING IS. THE THROMBIN VIAL WAS NOT IN CONTACT WITH THE PATIENT. THE NURSE NOTICED THE CHIP ON THE VIAL WHEN GETTING READY TO DISCARD THE EMPTY VIAL AFTER THE MEDICATION WAS MIXED AND ADMINISTERED BY THE SURGEON. THE NURSE NOTIFIED THE SURGEON RIGHT AWAY BUT THE SURGEON HAD ADMINISTERED IT ALREADY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905084 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERGOING SURGERY FOR A HERNIATED DISC IN THE CERVICAL SPINE. PEROPERATIVE BLEEDING TREATED WITH SURGIFLO. POSTOPERATIVELY AFFECTED COGNITION IS WHY THE PATIENT IS SENT AS A POSSIBLE STROKE CASE. INVESTIGATION SHOWS SMALL EMBOLI IN THE CEREBELLUM. SUSPICION OF SURGIFLO IN ARTERIA VERTEBRALIS. NO DAMAGE TO ARTERIA VERTIBRALIS HAS BEEN CONFIRMED ON CT ANGIO. DURING THE OPERATION, IT WAS ENSURED THAT THE BLEEDING WAS VENOUS. MORE DETAILED DESCRIPTION OF PATIENT/USER SEQUENCE: EFFECTS ON SYNCORTEX, PARTIAL BLINDNESS

  Patient problems: Embolism/Embolus; Loss of Vision

  MAUDE report 19041209 ↗
• InjuryApr 4, 2024Lack of Effect; Lack of Effect

  FOLLOW-UP INFORMATION WAS RECEIVED ON 06.03.2024 WHICH CHANGED THE INITIAL EVALUATION, AND THE CASE IS NOW CONSIDERED A NEAR ADVERSE EVENT. EVENT DESCRIPTION: REPORTED TO REP THAT SURGIFLO (2994) WAS NOT AS HEMOSTATIC AS FLOSEAL IN A PROCEDURE. THEY USED BOTH PRODUCTS. IT WAS ALSO REPORTED THAT SURGIFLO CREATED "CLOT ROCKS". THEY OPENED A FLOSEAL AND THE BLEEDING STOPPED TO COMPLETE THE PROCEDURE WITHOUT PATIENT HARM OR ANY OTHER ISSUES. NO DEVICE IS AVAILABLE FOR EVALUATION. FOLLOW-UP INFORMATION WAS RECEIVED ON 30.01.2024: THE THROMBIN WAS RECONSTITUTED. THE SURGEON STATED HE SEES CLOT ROCKS WHEN USED ON PATIENT. THE THROMBIN SOLUTION AND THE SURGIFLO HEMOSTATIC GELATIN MATRIX WERE MIXED 6 TIMES WITH NO PROBLEMS. THE SURGEON STATED HE SAW THE CLOT ROCKS UNDER THE MICROSCOPE AFTER USING IT ON THE PATIENT. THE GELATIN MATRIX WAS MIXED ACCORDING TO IFU. THE AMOUNT OF THE LIQUID USED FOR THE GELATINE MATRIX OF 2994 WAS AS MUCH AS WAS IN THE SYRINGE. THE MATRIX WAS MIXED PRIOR TO SURGERY AND USED WHEN NEEDED. ADDITIONAL INFORMATION WAS RECEIVED ON 06.03.2024 STATING: SURGIFLO WAS USED IN A CERVICAL SPINE PROCEDURE. BY "CLOT ROCKS" IT WAS MEANT THAT THE PRODUCT IS TURNING INTO SMALL RO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19039434 ↗
• InjuryMar 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REPORTED FROM ERD NURSE-EMERGENCY CALL: NURSE PRACTITIONER WAS SPLASHED WITH SURGIFLO HEMOSTATIC MATRIX, IN HER EYE BURNING SENSATION, FLUSHED THE EYE TREATED IT TETRICAINE, ANYTHING ELSE I NEED TO DO WITH IT? FLUSHED EYE FOR 15 MINUTES CONTACTED MA AND REPORTED TO COMPLAINTS DEPARTMENT. SENT MSDS AND IFU TO CUSTOMER VIA EMAIL, TOLD CUSTOMER TO GO TO THE ER AND FOLLOW UP WITH DOCTOR AND FLUSH EYES AT EYE STATION FOR 15-20 MINS AS WOULD WITH ANY CHEMICAL IN THE EYES. FOLLOW-UP INFORMATION WAS RECEIVED STATING: WHAT HAPPEN PRIOR THE "SPLASH" FROM SURGIFLO? PLEASE DESCRIBE, HOW DID IT HAPPEN? EMPLOYEE IS CERTIFIED SURGICAL TECH WHO WAS ASSISTING COWORKER GETTING READY FOR ANOTHER CASE. THEY HAVE USED THE PRODUCT MANY TIMES WITHOUT INCIDENT. THEY REPORTED AFTER MIXING THE LIQUID INTO THE DRY MATRIX THE 3RD TIME, ONE OF THE SYRINGE'S BROKE CAUSING THE MIXTURE TO SPRAY INTO THE EYES. THEY DO NOT REMEMBER WHICH SYRINGE BROKE BUT THEY ONLY MIXED THIS 3 TIMES OUT OF THE 6 RECOMMENDED TIMES. DID THE NURSE RECEIVED ANY OTHER TREATMENT? THEY WERE SENT TO THE OPHTHALMOLOGIST THE NEXT DAY FOR ASSESSMENT AFTER EYES WERE WASHED WITH WATER AND SALINE. WHAT IS THE STATUS OF THE NURSE? RECOVERED? PER

  Patient problems: Eye Irritation

  MAUDE report 18884669 ↗
• InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: SALES REP REPORTED FROM THE SURGEON THAT AFTER A PRESENTATION WITH A FOLLOW UP QUESTION AND SAID SHE HAD A PATIENT SHE PERFORMED LAP OVARIAN SURGERY ON AND USED SURGIFLO 2994 WITH LAP APPLICATOR AND PATIENT HAD SIGNIFICANT POST OP PAIN AND HAS BEEN READMITTED TWICE WITH OTHERWISE NORMAL WORK UP. SURGEON WANTED TO KNOW IF THERE ARE REPORTS OF INFLAMMATORY OR ALLERGIC TYPE REACTIONS TO SURGIFLO. REP PROVIDED PRODUCT IFU AND DISCUSSED KNOWN ADVERSE EVENTS AND DISCLOSED THAT I WOULD FILE THIS PRODUCT COMPLAINT. FOLLOW-UP INFORMATION: A RESPONSE WAS RECEIVED FROM THE SALES REP STATING THAT NO FURTHER INFORMATION WILL BE PROVIDED FOR THIS COMPLAINT. IN ADDITION NO PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 18795606 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SALES REP REPORTED THAT THE SURGEON USED 2994 ON VAGINAL CUSP, AFTER CLOSING WITH V-LOCK AND 2 WEEKS POST-OP PATIENT CAME BACK FINE FOLLOWING A LAPROSCOPICTOTAL HYSTERECTOMY PROCEDURE. ON WEEK 3 THERE WAS BLEEDING FOUND AND ONE SIDE OF THE CUSP WAS DEHISCED.

  Patient problems: Wound Dehiscence

  MAUDE report 18737535 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CASE WAS RECEIVED FROM ETHICON'S COMPLAINT TEAM. DURING FOLLOW-UP SURGIFLO WAS MENTIONED AS A DEVICE USED DURING INITIAL SURGERY AND THE CASE IS THEREFORE FORWARDED TO FERROSAN MEDICAL DEVICES A/S. THE INITIAL CASE HANDLED BY ETHICON (ETHICON DEVICE) WAS RECEIVED 03.01.2024. FOLLOW-UP INFORMATION IMPLICATING SURGIFLO WAS RECEIVED 19.01.2024. INITIAL INFORMATION: SALES REP REPORTED THAT A PATIENT HAD TO COME BACK TO HAVE VAGINAL CUSP TODAY ON (B)(6) 2024 RECLOSED DUE TO IT DEHISCING. REP WILL SEND REST OF PRODUCT WITHIN REMAINING ASSOCIATED LOT NUMBER FOR ANALYSIS. FOLLOW-UP INFORMATION: IT WAS REPORTED BY THE SALES REP THAT POST OP OF AN OPEN HYSTERECTOMY, VAGINAL CUFF DEHISCENCE. THE PATIENT CAME BACK FOR REOPERATION ON (B)(6) 2024. 2994 X 2. AT THE TIME OF THE CALL PATIENT HARM WAS UNKNOWN. THE SURGEON IS WONDERING IF THE USE OF THE DOUBLE 2994 IS WHAT LED TO THE DEHISCENCE.

  Patient problems: Wound Dehiscence

  MAUDE report 18649141 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CASE WAS RECEIVED FROM ETHICON'S COMPLAINT TEAM. DURING FOLLOW-UP SURGIFLO WAS MENTIONED AS A DEVICE USED DURING INITIAL SURGERY AND THE CASE IS THEREFORE FORWARDED TO FERROSAN MEDICAL DEVICES A/S. THE INITIAL CASE HANDLED BY ETHICON (ETHICON DEVICE) WAS RECEIVED 03.01.2024. FOLLOW-UP INFORMATION IMPLICATING SURGIFLO WAS RECEIVED 19.01.2024. INITIAL INFORMATION: SALES REP REPORTED THAT A PATIENT HAD TO COME BACK TO HAVE VAGINAL CUSP TODAY ON (B)(6) 2024 RECLOSED DUE TO IT DEHISCING. FOLLOW-UP INFORMATION: IT WAS REPORTED BY THE SALES REP THAT POST OP OF AN OPEN HYSTERECTOMY, VAGINAL CUFF DEHISCENCE. THE PATIENT CAME BACK FOR REOPERATION ON (B)(6), 2024. 2994 X 2. AT THE TIME OF THE CALL PATIENT HARM WAS UNKNOWN. THE SURGEON IS WONDERING IF THE USE OF THE (B)(6) IS WHAT LED TO THE DEHISCENCE.

  Patient problems: Wound Dehiscence

  MAUDE report 18649082 ↗
• InjuryNov 21, 2023Off-Label Use; Off-Label Use

  ARTICLE TITLE: CAN NEAR-INFRARED IMAGING DISTINGUISH A GELATIN-BASED MATRIX GRANULOMA FROM A MALIGNANCY IN A KIDNEY? AUTHORS: BURAK KOSEOGLU, ALI YASIN OZERCAN, AYSEL COLAK, SERDAR BASBOGA & ALTUG TUNCEL CITATION: MINIMALLY INVASIVE THERAPY & ALLIED TECHNOLOGIES, DOI: 10.1080/13645706.2023.2272968. THIS STUDY PRESENTS A CASE OF A 62-YEAR-OLD MALE PATIENT WHO UNDERWENT TRANSPERITONEAL LAPAROSCOPIC RENAL CYST DECORTICATION EIGHT YEARS EARLIER FOR BENIGN RENAL CYST OF 5 CM IN DIAMETER LOCATED IN THE LOWER POLE OF THE LEFT KIDNEY. HIS PREVIOUS SURGICAL RECORDS REVEALED THAT A GELATIN-BASED HEMOSTATIC MATRIX (SURGIFLO) HAD BEEN USED ON THE BASE OF THE SURGICAL SITE TO PROVIDE EFFICIENT HEMOSTASIS. REPORTED COMPLICATIONS INCLUDE LEFT LUMBAR PAIN. CONTRAST-ENHANCED ABDOMINAL CT IMAGING REVEALED A BOSNIAK TYPE-4 CYST OF 4CM IN DIAMETER, PRESENTING WITH A SEMI-SOLID COMPONENT AT THE PREVIOUS SURGICAL SITE (FIGURE 1A). IN CONCLUSION, IT IS IMPORTANT TO CONSIDER THE POSSIBILITY OF A FOREIGN BODY GRANULOMA FROM SURGIFLO, WHICH MAY MIMIC A NEOPLASTIC KIDNEY LESION IN RADIOLOGICAL APPEARANCE IN SIMILAR CASES. CLINICIANS SHOULD ALSO BE AWARE THAT NIRF IMAGING WITH ICG MAY NOT CONTRIBUTE TO DISTIN

  Patient problems: Foreign Body Reaction; Granuloma; Pain

  MAUDE report 18182003 ↗
• InjuryNov 13, 2023Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT POST-OP OF AN ANTERIOR CORPECTOMY PROCEDURE THE DURING AN MRI IT SHOWED THE SURGIFLOW (CORRECTED TO SURGIFLO¿) WAS "CREEPING AROUND" CAUSING STENOSIS. PATIENT WAS BROUGHT BACK TO OR TO SCRAPE OUT THE SURGIFLOW (CORRECTED TO SURGIFLO¿). PATIENT IS NOW DOING FINE. THE SURGEON REMOVED THE SURGIFLO DURING THE 2ND PROCEDURE. FOLLOW-UP INFORMATION: SURGIFLO WAS USED TO CONTROL BLEEDING IN AN ANTERIOR CORPECTOMY. SURGIFLO WAS USED FOR ADJUNCTIVE HEMOSTASIS. IT IS UNKNOWN WHETHER EXCESS SURGIFLO WAS REMOVED.

  Patient problems: Pain; Stenosis

  MAUDE report 18118002 ↗
• InjuryOct 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  SALES REP REPORTED THAT THERE WAS BRAIN SWELLING CAUSED FROM THE SURGIFLO 2994. THIS CASE IS NULLIFIED (CANCELLED) AS IT IS A DOUBLICATE IF PREVIOUSLY REPORTED ADVERSE EVENT. MFR REPORT #: 3008478369-2023-00012.

  Patient problems: Swelling/ Edema

  MAUDE report 18019807 ↗
• InjuryOct 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO THE SALES REP THAT DURING A CRANIOTOMY PROCEDURE THAT THE DOCTOR PUT SURGIFLO IN A CAVERNOMA AND THE PATIENT STARTED EXPERIENCING BRADYCARDIA. ONCE SURGIFLO WAS REMOVED THE PATIENT RETURNED BACK TO BASELINE. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO LONG TERM ADVERSE CONSEQUENCES FOR THE PATIENT. AN ALLERGIC REACTION CANNOT BE RULED OUT BASED ON THE AVAILABLE INFORMATION. THE SURGEON'S OPINION TO THE CAUSE OF THE BRADYCARDIA WAS STATED AS "SURGIFLO". FOLLOW-UP INFORMATION: SURGIFLO WAS USED ON-LABEL. FOLLOW-IP IMFORMATION NO. 2: SALES REPRESENTATIVE REPORTED THAT THERE WAS BRAIN SWELLING CAUSED FROM THE SURGIFLO 2994.

  Patient problems: Cardiovascular Dysfunction/Insufficiency; Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 18019773 ↗
• MalfunctionJun 27, 2023Fluid/Blood Leak

  WHEN SCRUB PERSON TRIED TO MIX THE SURGIFLO NONE OF THE FLUID WENT INTO THE VIAL. THE FLUID RAN OUT FROM UNDER THE TRANSFER CAP AND DOWN THE SIDES OF THE BOTTLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17208384 ↗

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-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-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-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