Strattice Reconstructive Tissue Matrix 2030002Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI M32820300020), received between Oct 22, 2018 and Aug 27, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH 1ST STRATTICE AND 2ND STRATTICE FIRM ON (B)(6) 2023. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION WAS PROVIDED ON THE INDICATION FOR THE INITIAL SURGERY OR THE REASON FOR THE REMOVAL OR REVISION. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6) ((B)(4)). THIS EMDR IS BEING SUBMITTED FOR THE 1ST STRATTICE.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Post Operative Wound Infection; Seroma

  MAUDE report 22903543 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE FIRM ON (B)(6) 2019. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION WAS PROVIDED ON THE INDICATION FOR THE INITIAL SURGERY OR THE REASON FOR THE REMOVAL OR REVISION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia

  MAUDE report 21267332 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON 16/AUG/2024, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. AS PER THE PPF FORM, THE PATIENT UNDERWENT A VENTRAL HERNIA SURGERY AND WAS IMPLANTED WITH A STRATTICE DEVICE LOT #SPJ00518-132 (NOT VALID) AND REF. #(B)(4) ON (B)(6) 2017. ON (B)(6) 2021, PATIENT UNDERWENT EXPLORATORY LAPAROTOMY WITH EXTENSIVE LYSIS OF ADHESIONS, RADICAL EXCISIONAL DEBRIDEMENT OF ABDOMINAL WALL, INCLUDING SKIN/SCAR/STSG/SUBQ/MYOFASCIAL TISSUE, INCISION AND DRAINAGE OF ABDOMINAL WALL FLUID COLLECTION, RESECTION OF INFECTED MESH, AND REMOVAL OF INTRA-ABDOMINAL ABSCESS/SUTURE MATER. THE STRATTICE WAS REMOVED AND PATIENT WAS IMPLANTED WITH ANOTHER STRATTICE DEVICE LOT #SP200287-058 ON (B)(6) 2021. PATIENT LATER EXPERIENCING SOME ISSUES WITH THE MESH POTENTIALLY CURLING UP. THE FORM LISTS THE CONDITION THAT WAS TREATED WAS: ADHESIONS, INFECTION, DRAINAGE, ABSCESS BETWEEN (B)(6) 2021. THE PPF FORM ALSO INDICATES THAT THE PATIENT WAS IMPLANTED WITH A NON-ABBVIE DEVICE, GORE-TEX, LOT #UNKNOWN IN 2001 AND BARD SOFT MESH LOT # HUAU1707 WITH BARD SOFT MESH LOT #HUAV0166 SOFT PRO ON (B)(6) 2016. THE FORM INDICATES THAT TH

  Patient problems: Abscess; Adhesion(s); Hernia; Post Operative Wound Infection; Seroma

  MAUDE report 19533468 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 59 YEAR OLD FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2013. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH; LOT # SP100043-148 REF # 2030002. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2014, FOR REPAIR OF A RECURRENT VENTRAL HERNIA. ON OR ABOUT (B)(6) 2020, THE PATIENT HAD ANOTHER STRATTICE MESH IMPLANTED FOR VENTRAL HERNIA REPAIR. THE LOT# IS SP200144-137 AND THE REF# IS 20300002. IN (B)(6) 2022, THE PATIENT PRESENTED TO THE HOSPITAL FOR A REVISION SURGERY. THIS RECORD IS ASSOCIATED WITH SP200144-137 REF # 2030002; IMPLANTED (B)(6) 2020.

  Patient problems: Hernia

  MAUDE report 16051558 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A LEGAL EVENT THAT A (B)(6) MALE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2016. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE RECONSTRUCTIVE TISSUE MATRIX ITEM 2030002, LOT SP100368 MESH IN HIM. AFTER SURGERY, 5 YEARS LATER, THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2021.

  Patient problems: Hernia

  MAUDE report 14457481 ↗
• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A LEGAL EVENT THAT A (B)(6) MALE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2019. DURING THE PATIENT¿S SURGERY, THE SURGEON IMPLANTED HIM WITH STRATTICE LOT SP100606 (SKU 2030002). AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2020, AND WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA, ADHESIONS, CHRONIC SEROMA, AND SMALL BOWL LINING DETERIORATION DUE TO MESH. ON OR ABOUT (B)(6) 2020, THE PATIENT UNDERWENT LYSIS OF ADHESIONS AND HERNIA REPAIR. DURING THIS REVISION SURGERY, THE SURGEON NOTED INTRA-ABDOMINAL ADHESIONS INVOLVING THE SMALL BOWEL, OMENTUM, TRANSVEST COLON, ANTERIOR ABDOMINAL WALL, AND PREVIOUSLY PLACED MESH. THE SURGEON ALSO NOTED THAT THE GRAFT APPEARED FOLDED ON ITSELF AND BUNCHED UP ALONG THE FASCIAL DEFECT. MULTIPLE LOOPS OF SMALL BOWEL WERE NOTED TO BE DECENTLY ADHERENT MESH WITH SEROSAL EROSION AND A SEROMA ANTERIOR TO THE PREVIOUSLY PLACED MESH. IT SHOULD BE THE NOTED THE LOT NUMBER WAS PROVIDED WITHOUT THE SERIAL NUMBER AND THE ITEM NUMBER THAT CORRELATES IS 2030002P.

  Patient problems: Erosion; Hernia; Seroma

  MAUDE report 14435248 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A (B)(6) FEMALE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2014. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THIS IS A STRATTICE FIRM 20 X 30 MESH. AFTER SURGERY, THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2017.

  Patient problems: Hernia

  MAUDE report 14148310 ↗
• InjuryApr 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A LEGAL EVENT THAT A (B)(6) FEMALE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON OR ABOUT (B)(6), 2019. DURING SURGERY, THE SURGEON IMPLANTED A STRATTICE FIRM MESH. AFTER SURGERY, THE PATIENT WAS DIAGNOSED WITH AN ABDOMINAL WALL NECROTIZING SOFT TISSUE INFECTION AND HAD A WOUND DEBRIDEMENT AND PLACEMENT OF ADDITIONAL MESH ON (B)(6) 2019. ON (B)(6) 2019, DUE TO THE CHRONIC ABDOMINAL WOUND INFECTION, THE PATIENT HAD A WOUND DEBRIDEMENT AND PLACEMENT OF A WOUND VAC. ON (B)(6) 2020, SHE HAD AN EXPLANT OF MESH, REPAIR OF ENTEROCUTANEOUS FISTULA AND REPAIR OF PARASTOMAL HERNIA. THIS RECORD IS ASSOCIATED WITH THE FIRST MESH IMPLANTED ON (B)(6) 2019.

  Patient problems: Bacterial Infection; Necrosis

  MAUDE report 14136496 ↗
• InjuryMar 7, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  LEGAL AFFAIRS REPORTS PATIENT UNDERWENT INCISIONAL HERNIA REPAIR SURGERY. STRATTICE MESH IMPLANTED. PATIENT RETURNED TO HOSPITAL 1.5 YEARS LATER BECAUSE OF ABDOMINAL WALL ABSCESS AND UNINCORPORATED MESH REQUIRING REMOVAL OF THE MESH. MESH REMOVED.

  Patient problems: Abscess

  MAUDE report 11427070 ↗
• InjuryOct 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED INFORMATION WAS RECEIVED ON 24/OCT/2018 THAT THIS IS A 48 YEAR OLD MALE WITH A PAST MEDICAL HISTORY OF MULTIPLE ABDOMINAL SURGERIES INCLUDING EXPLORATORY LAPAROTOMY WITH SMALL BOWEL RESECTION, ILEOSTOMY AND ILEOSTOMY TAKEDOWN. THE PATIENT DEVELOPED AN ENTEROCUTANEOUS FISTULA AND WAS ON IV ANTIBIOTICS DURING THEIR HOSPITAL STAY, DAILY WOUND CARE AND TPN. THE PATIENT PRESENTED WITH INFECTION ON 24/JUL/2018. MULTIPLE CULTURES WERE TAKEN THROUGHOUT THE COURSE OF MONTHS IN THE HOSPITAL WITH MANY RESISTANT ORGANISMS (SPECIES NOT REPORTED). WHEN THE PATIENT WAS RETURNED TO SURGERY ON 01/OCT/2018, THE STRATTICE DEVICE WAS NOT EXPLANTED. THE PATIENT SUBSEQUENTLY DIED ON POST-OP DAY 2 DUE TO MEDICAL BLEEDING. THE SURGEON DOES NOT ATTRIBUTE STRATTICE AS A CAUSE OR CONTRIBUTOR TO THE INITIAL REPORTED INFECTION AND THAT THE PATIENT HAD POOR NUTRITION AND OVERALL HEALTH STATUS. AS REPORTED IN THE INITIAL: IT WAS REPORTED THAT A PATIENT UNDERWENT ABDOMINAL WALL RECONSTRUCTION WITH STRATTICE, ENTEROLYSIS AND "ENCOLOSTOMY" TAKEDOWN FOR A LARGE VENTRAL ABDOMINAL WALL HERNIA ON 06/FEB/2018. NO FASCIA APPROXIMATION WAS ACHIEVED AND THE STRATTICE WAS PLACED IN UNDERLAY FASHION AND FIXED TO THE

  Patient problems: Death; Fistula; Unspecified Infection

  MAUDE report 7991751 ↗