Strattice Reconstructive Tissue Matrix 0816001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M32808160010), received between Aug 28, 2025 and Aug 28, 2025 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 14/AUG/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 AN ¿INCISIONAL HERNIA¿ SURGERY AND WAS IMPLANTED WITH TWO STRATTICE DEVICES ON (B)(6) 2018. THE PATIENT UNDERWENT AN ¿INCISION & DRAINAGE OF ABDOMINAL WALL ABSCESS, DEBRIDEMENT¿ ON (B)(6) 2019. THE PATIENT UNDERWENT AN ¿ABSCESS DRAINAGE/INCISION & DRAINAGE¿ ON (B)(6) 2021. THE PATIENT UNDERWENT AN ¿INCISION & DRAINAGE¿ ON (B)(6) 2021. THE PATIENT UNDERWENT A ¿NON-HEALING SUTURE ABSCESS, SUTURE REMOVAL, ABSCESS CAVITY DEBRIDED¿ ON (B)(6) 2021. THE FORM LISTS THE CONDITIONS THAT WERE TREATED WERE ¿OPEN INCISIONAL HERNIA REPAIR (2-LAYER SANDWICH MESH REPAIR WITH STRATTICE AND A PRIMARY FASCIA CLOSURE); ABSCESS CAVITY DEBRIDED¿ BETWEEN (B)(6) 2018 AND (B)(6) 2018. THE PATIENT WAS THEN TREATED FOR ¿INCISION & DRAINAGE OF ABDOMINAL WALL ABSCESS; DEBRIDEMENT¿ ON (B)(6) 2019. THE PATIENT RECEIVED TREATMENT FOR ¿ABDOMINAL WALL PAIN; ABDOMINAL WALL ABSCESS; ABSCESS DRAINAGE/INCISION & DRAINAGE¿ ON OR ABOUT (B)(6) 2021. THE PATIENT RECEIVED ¿INCISION & DRAINAGE; CHRONIC ABDOMINAL WOUND INFECTION; SUTURE ABSCESS (SUTURE CUT);

  Patient problems: Abscess; Cellulitis; Post Operative Wound Infection

  MAUDE report 22916210 ↗