Strattice Reconstructive Tissue Matrix 2020002Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI M32820200020), received between Feb 25, 2021 and Mar 14, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2025No Apparent Adverse Event; No Apparent Adverse Event

  LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE FIRM ON (B)(6) 2012. 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: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Post Operative Wound Infection

  MAUDE report 21610507 ↗
• InjuryJul 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON (B)(6) 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 STRATTICE DEVICE LOT UNKNOWN AND REF# (B)(4) ON (B)(6) 2023. ON (B)(6) 2024, PATIENT UNDERWENT EXPLANT MESH WITH ENTEROLYSIS OF ADHESIONS & IMPLANT ADDITIONAL MESH (NON-ABBIVE DEVICE) UNDERLAY AND ONLAY FOR RECURRENT VENTRAL HERNIA REPAIR WITH JP DRAIN X 3 PLACEMENT. AS PER THE PPF FORM, THE PATIENT CLAIMS: INTERVENTIONAL REVISION AND REMOVAL SURGERIES, HERNIA RECURRENCE, PAIN, MESH EXPLANT, MESH REVISION, ADDITIONAL MESH IMPLANT, JP DRAIN X 3 PLACEMENT THE FORM LISTS THE CONDITION THAT WAS TREATED: INTERVENTIONAL REVISION AND REMOVAL SURGERIES, HERNIA RECURRENCE, PAIN, MESH EXPLANT, MESH REVISION, ADDITIONAL MESH IMPLANT, JP DRAIN X 3 PLACEMENT BETWEEN (B)(6) 2023 - (B)(6) 2024. THE PPF FORM ALSO INDICATES THAT THE PATIENT WAS IMPLANTED WITH A NON-ABBVIE DEVICE, BARD VENTRALIGHT ST; LOT #: UNKNOWN; REF #: (B)(4) ON (B)(6)2023. PATIENT WAS IMPLANTED WITH ANOTHER NON-ABBVIE DEVICE, BARD VENTRALIGHT ST; LOT #: UNKNOWN; REF #: (B)(4) ON (B)(

  Patient problems: Adhesion(s); Hernia

  MAUDE report 19868225 ↗
• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON 7/20/2023, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE LOT ASSOCIATED WITH THIS EVENT WAS FOUND THROUGH DISCOVERY AND IS SP100441-177. NO OTHER INFORMATION WAS REPORTED. AS REPORTED IN THE INITIAL: IT WAS REPORTED FROM A LEGAL EVENT THAT A 67 YEAR OLD MALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2017. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2021, FOR A REVISION SURGERY. NO OTHER INFORMATION WAS REPORTED.

  Patient problems: Hernia

  MAUDE report 16691273 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON 6/26/2023, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE LOT ASSOCIATED WITH THIS EVENT WAS FOUND THROUGH DISCOVERY AND IS SP100196-294 (9/3/2015). NO OTHER INFORMATION WAS REPORTED. AS REPORTED IN THE INITIAL: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 52 YEAR OLD MALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2015. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH.THE RECORDS INDICATE THIS IS A STRATTICE AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2016, FOR A REVISION SURGERY. DURING THE REVISION SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. NO OTHER INFORMATION AS PROVIDED. THERE IS NO ALLEGATION OR OCCURRENCE REPORTED AFTER THE SECOND DEVICE WAS IMPLANTED; THEREFORE NO ADDITIONAL RECORD WILL BE OPENED.

  Patient problems: Hernia

  MAUDE report 16591346 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A LEGAL EVENT THAT A MALE PATIENT HAD A HERNIA REPAIR SURGERY PRIOR TO (B)(6) 2009, DURING WHICH A STRATTICE HERNIA MESH WAS IMPLANTED. THE LOT AND BATCH NUMBERS FOR THAT MESH ARE UNKNOWN AT THIS TIME. ON (B)(6) 2009, THE PATIENT UNDERWENT A REVISION/REMOVAL SURGERY AND A SECOND STRATTICE HERNIA MESH WAS IMPLANTED. THE RECORDS INDICATE THIS IS A STRATTICE FIRM 20 X 20 CM MESH. THE LOT AND BATCH NUMBERS FOR THAT MESH ARE S10432-021. THE CATALOG AND SERIAL NUMBERS FOR THAT MESH ARE 2020002. AFTER SURGERY, THE PATIENT HAD A SECOND REVISION/REMOVAL SURGERY ON (B)(6) 2013. NO OTHER INFORMATION WAS PROVIDED. THIS RECORD IS ASSOCIATED WITH THE SECOND DEVICE IMPLANTED; DATE UNKNOWN; LOT S10432-021. ALTHOUGH A LOT NUMBER WAS REPORTED; S10432-021 IS NOT A VALID LOT NUMBER AND THEREFORE UPDATED TO UNKNOWN. BASED ON THE INFORMATION REPORTED, THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2009 WITH LOT UNKNOWN. IT WAS REPORTED THE PATIENT UNDERWENT REVISION/DEVICE REMOVAL AND IMPLANTED WITH A SECOND DEVICE ON THE SAME DAY, WHICH DOES NOT SEEM PLAUSIBLE. IT WAS ALSO REPORTED THE PATIENT UNDERWENT REVISION/REMOVAL SURGERY IN MARCH 2013 BUT SINCE THE IMPLANT DATES DO NOT ADD

  Patient problems: Hernia

  MAUDE report 16091238 ↗
• InjurySep 22, 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 62 YEAR OLD MALE PATIENT HAD A VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2014. DURING THE HERNIA REPAIR SURGERY THE SURGEON IMPLANTED A STRATTICE MESH, LOT SP100069-080, CATALOG 2030002. AFTER SURGERY, THE PATIENT HAD A REVISION SURGERY WHICH INCLUDED A RECURRENT VENTRAL HERNIA REPAIR, LYSIS OF EXTENSIVE ADHESIONS AND REPAIR OF SMALL BOWEL OBSTRUCTION ON (B)(6) 2016. DURING THE HERNIA REPAIR SURGERY AN ADDITIONAL STRATTICE MESH WAS IMPLANTED, THE RECORDS INDICATE THIS IS A STRATTICE FIRM; THE LOT NUMBER FOR THAT MESH IS SP100280-022. THE CATALOG IS 220008. THE CATALOG ITEM NUMBER FOR LOT SP100280-022 IS NOT VALID. HOWEVER; THE LOT NUMBER IS AND IS ASSOCIATED WITH CATALOG ITEM 2020002. ON (B)(6) 2017, HE HAD SURGERY FOR A RECURRENT VENTRAL HERNIA DUE TO THE FAILED STRATTICE IMPLANTS. THIS RECORD IS ASSOCIATED WITH LOT SP100280-022 IMPLANTED ON (B)(6) 2016.

  Patient problems: Hernia

  MAUDE report 15462798 ↗
• InjuryMay 4, 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 A PRIMARY VENTRAL HERNIA REPAIR ON OR ABOUT (B)(6) 2011. DURING THE SURGERY, THE SURGEON IMPLANTED STRATTICE MESH LOT B-10960, CATALOG 2020002. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2015 AND WAS DIAGNOSED WITH ABSCESSES WHERE THE STRATTICE MESH WAS TACKED INTO PLACE. ON (B)(6) 2015, THE PATIENT HAD INCISION AND DRAINAGE OF ABDOMINAL CYSTS AND MESH REMOVAL. IT SHOULD BE NOTED THE LOT NUMBER PROVIDED IS NOT POPULATING AS A VALID LOT, THEREFORE, THE LOT ASSOCIATED WITH THIS EVENT IS UNKNOWN. THE CATALOG/ITEM NUMBER IS VALID.

  Patient problems: Bacterial Infection

  MAUDE report 14273399 ↗
• InjuryJul 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS REPORTED TO ABBVIE ON JUNE 22, 20022 REPORTING THE LOT NUMBER ASSOCIATED WITH THIS COMPLAINT, LOT S11222-65 WAS IMPLANTED ON (B)(6) 2013.

  Patient problems: Hernia; Post Operative Wound Infection

  MAUDE report 12175927 ↗
• InjuryJun 22, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  THIS IS FOLLOW UP# 1 TO REPORT ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 4/12/2022 THAT STATES THE LOT NUMBER ASSOCIATED WITH THIS EVENT IS DOCUMENTED AS SP100194-024. AS REPORTED IN THE INITIAL: PATIENT REPRESENTATIVE REPORTED PATIENT HAD STRATTICE, IMPLANTED ON (B)(6) 2015 FOR A HERNIA REPAIR. STRATTICE WAS EXPLANTED ON (B)(6) 2016. LOT NUMBER REMAINS UNKNOWN.

  Patient problems: Hernia; Insufficient Information

  MAUDE report 12041796 ↗
• InjuryMay 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPANY REPRESENTATIVE REPORTS HERNIA REVISION ON ()(6) 2013 USING STRATTICE. ON (B)(6) 2013 PATIENT WAS DIAGNOSIS WITH A MIDLINE INFECTION SECONDARY TO THE STRATTICE. ON (B)(6) 2015, PATIENT WAS HOSPITALIZED FOR A RECURRENT HERNIA. LOT NUMBERS REMAIN UNKNOWN.

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

  MAUDE report 11853083 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY INCISIONAL HERNIA REPAIR. STRATTICE MESH IMPLANTED. PATIENT RETURNED TO THE HOSPITAL 7 MONTHS LATER AND WAS DIAGNOSED WITH WORSENING SYMPTOMATIC ENLARGING EPIGASTRIC INCISIONAL HERNIA. HERNIA MESH REVISION SURGERY COMPLETED.

  Patient problems: Hernia

  MAUDE report 11614916 ↗
• InjuryFeb 25, 2021Patient-Device Incompatibility; Material Integrity Problem; Patient-Device Incompatibility; Material Integrity Problem

  PATIENT UNDERWENT SPIGELIAN HERNIA REPAIR SURGERY. SURGEON IMPLANTED STRATTICE MESH (LOT/BATCH: SP100237-231, CATALOG/REFERENCE #: 2020002). APPROXIMATELY 3.5 YEARS LATER,PATIENT RETURNED TO THE HOSPITAL AND WAS DIAGNOSED WITH A SEROMA AND NONINTEGRATED BIOLOGIC ABDOMINAL REINFORCEMENT MATRIX. SURGEON NOTICED THAT THE MESH SPLIT IN HALF REQUIRING REMOVAL.

  Patient problems: Seroma

  MAUDE report 11379832 ↗