Strattice Reconstructive Tissue Matrix Perforated 1620002PRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M3281620002P0), received between Feb 1, 2021 and Apr 21, 2025 — classified as 7 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON 2/SEP/2025, 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 RECURRENT INCARCERATED INCISIONAL SURGERY AND HERNIA SUPRAUMBILICAL AND EPIGASTRIC. PATIENT WAS IMPLANTED WITH A STRATTICE DEVICE LOT #SP20002P, REF. #(B)(4) ON (B)(6) 2018. ON (B)(6) 2019, PATIENT UNDERWENT A REPAIR HERNIA INGUINAL W/TEP LAPAROSCOPIC WITH MESH. THE FORM LISTS THE CONDITION THAT WAS TREATED: (B)(6) 2018: OPEN REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA SUPRAUMBILICAL AND EPIGASTRIC, REMOVAL OF MESH SYNTHETIC, PLACEMENT OF A STRATTICE BIOLOGICAL MESH IN THE RETRORECTUS UNDERLAY POSITION; INCIDENTAL APPENDECTOMY. (B)(6) 2018: ABDOMINAL PAIN; ABDOMINAL WALL SEROMA. (B)(6) 019: REPAIR HERNIA INGUINAL WITH TEP LAPAROSCOPIC WITH MESH (MESH IMPLANT X 2); SEROMA DRAINED. APPROX. 2020-PRESENT: PAIN MANAGEMENT. AS REPORTED IN THE INITIAL: LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE ON (B)(6) 2018. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION

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

  MAUDE report 21876688 ↗
• InjurySep 5, 2024Adverse 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 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: Abscess; Adhesion(s); Cellulitis; Hernia; Obstruction/Occlusion; Post Operative Wound Infection; Seroma

  MAUDE report 20152867 ↗
• InjurySep 12, 2023Adverse 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 PERFORATED ON (B)(6) 2022. 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: Hernia; Seroma

  MAUDE report 17733140 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON 03/AUG/2023, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. AS PER THE PPF FORM, THE PATIENT WAS IMPLANTED WITH STRATTICE DEVICE LOT SP200184, 1620002P ON 24/JAN/2020. HOWEVER THE TYPE OF HERNIA SURGERY WAS NOT PROVIDED. DURING THE SAME SURGERY, THE PATIENT WAS ALSO IMPLANTED WITH A NON-ABBVIE DEVICE. THE PATIENT UNDERWENT ¿INCISION AND DRAINAGE OF INFECTION ABDOMINAL WALL ABSCESS, REMOVAL OF INTRABDOMINAL MESH, CONTROL OF COLOCUTANEOUS FISTULA¿ AND WAS TREATED FOR ¿ABSCESS¿, ¿FISTULA" WITH WOUND VAC PLACEMENT ON (B)(6) 2021 WHERE STRATTICE WAS REPORTED TO BE EXPLANTED. NO OTHER INFORMATION WAS PROVIDED. THE EVENT OF "REHERNIATION" WAS REMOVED AS IT DOES NOT APPEAR THIS PATIENT EXPERIENCED A RECURRENCE WITH STRATTICE. AS REPORTED IN THE INITIAL: LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE PERFORATED ON (B)(6) 2020. 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: Bacterial Infection; Fistula; Hernia

  MAUDE report 17190025 ↗
• InjuryJul 12, 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 HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2019. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE PERFORATED MESH, 1620002P AND THE LOT NUMBER IS SP200029-123. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2020 AND WAS DIAGNOSED WITH A RECURRENT VENTRAL HERNIA. ON OR ABOUT (B)(6) 2020, THE PATIENT UNDERWENT A REVISION SURGERY. OMENTAL ADHESIONS WERE NOTED AND FREED, AND THE LARGE RECURRENT HERNIA WAS REPAIRED. ON OR ABOUT (B)(6) 2021, THE PATIENT PRESENTED TO (B)(6) IN (B)(6) AND WAS NOTED TO HAVE RECURRENT HERNIAS. HE UNDERWENT A REVISION AND REMOVAL SURGERY TO REPAIR THE RECURRENT HERNIAS, WHERE ADHESIONS WERE NOTED AND A PORTION OF THE MESH WAS DISSECTED OUT.

  Patient problems: Hernia

  MAUDE report 14990452 ↗
• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A LEGAL SUMMONS THAT A (B)(6) FEMALE UNDERWENT AN INCISIONAL HERNIA REPAIR IN TULSA, OK ON (B)(6) 2018 AND WAS IMPLANTED WITH STRATTICE LOT SP1000628-153. THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2018, WAS DIAGNOSED WITH A SEVERE INFECTION, AT WHICH TIME SHE UNDERWENT PARACENTESIS TWICE AND UNDERWENT SURGICAL DRAINAGE AND WOUND VAC PLACEMENT. WOUND CULTURES TAKEN AT THE TIME OF THIS ADMISSION TESTED POSITIVE FOR MRSA POSTURAL AN STRETOCOCCUS. ON (B)(6) 2018 THE PATIENT WAS DIAGNOSED WITH MULTIPLE ABDOMINAL WALL ABSCESSES DUE TO A NON-HEALING ABDOMINAL WOUND. THE PATIENT THEN UNDERWENT DRAINAGE OF ABDOMINAL WALL ABSCESSES RELATED TO HER ONGOING POST-SURGICAL INFECTION AND PAIN. ON (B)(6) 2019, SHE WAS DIAGNOSED WITH A RECURRENT HERNIA. ON (B)(6) 2019 SHE PRESENTED TO ST. LOUIS UNIVERSITY HOSPITAL WITH AN INFECTED ABDOMINAL WOUND WHICH DID NOT RESPOND TO TREATMENT. SHE CONTINUE TO SUFFER FROM INFECTION UNTIL THE PATIENT DIED ON (B)(6) 2019.

  Patient problems: Hernia

  MAUDE report 12509085 ↗
• InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTS PRIMARY VENTRAL HERNIA REPAIR WITH STRATTICE MESH (MATERIAL #: 1620002P, SERIAL #: (B)(4)). PATIENT EXPERIENCED CHRONIC ABDOMINAL WALL ABSCESS, INFECTED UNINCORPORATED MESH. PRODUCT EXPLANTED 6 MONTHS LATER.

  Patient problems: Unspecified Infection

  MAUDE report 11259134 ↗