Strattice Reconstructive Tissue Matrix 0808002Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M32808080020), received between Sep 22, 2022 and Nov 16, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 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 ON (B)(6) 2018. 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); Hernia; Obstruction/Occlusion

  MAUDE report 18155048 ↗
• InjuryJan 12, 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 71 YEAR OLD MALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2013. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THIS IS A LIFECELL ¿ STRATTICE MESH (LOT # SP1000005-149 REF # 1010002). AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2015, FOR A REVISION SURGERY AND ADDITIONAL STRATTICE MESH WAS IMPLANTED. THE RECORDS INDICATE THIS IS A LIFECELL ¿ STRATTICE MESH (LOT # SP100157 REF #1016002). ON (B)(6) 2016, THE PATIENT UNDERWENT AN INCISIONAL VENTRAL HERNIA REPAIR WITH STRATTICE. THE RECORDS INDICATE THAT TWO STRATTICE WERE IMPLANTED (CAT # 0808002 LOT # SP100300- 213; LOT # SP100176-204). IT WAS REPORTED THE PATIENT UNDERWENT MULTIPLE SUBSEQUENT RECURRENT VENTRAL AND INCISIONAL HERNIA REPAIR SURGERIES. NO OTHER INFORMATION WAS PROVIDED. THIS RECORD IS ASSOCIATED WITH DEVICE LOT # 0808002 LOT # SP100176-204; IMPLANTED (B)(6) 2016.

  Patient problems: Hernia

  MAUDE report 16151999 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP# TO REPORT THE RESULTS FROM THE INTERNAL INVESTIGATION AND THE CONCLUSION. THE AWARE DATE IS BASED ON WHEN THE BATCH RECORD REVIEW WAS COMPLETED. AS REPORTED IN THE INITIAL: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 71 YEAR OLD MALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6), 2013. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THIS IS A LIFECELL ¿ STRATTICE MESH (LOT # SP1000005-149 REF # 1010002). AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2015, FOR A REVISION SURGERY AND ADDITIONAL STRATTICE MESH WAS IMPLANTED.THE RECORDS INDICATE THIS IS A LIFECELL ¿ STRATTICE MESH (LOT # SP100157 REF #1016002). ON (B)(6), 2016, THE PATIENT UNDERWENT AN INCISIONAL VENTRAL HERNIA REPAIR WITH STRATTICE. THE RECORDS INDICATE THAT TWO STRATTICE WERE IMPLANTED (CAT # 0808002 LOT # SP100300- 213; LOT # SP100176-204). IT WAS REPORTED THE PATIENT UNDERWENT MULTIPLE SUBSEQUENT RECURRENT VENTRAL AND INCISIONAL HERNIA REPAIR SURGERIES. NO OTHER INFORMATION WAS PROVIDED. THIS RECORD IS ASSOCIATED WITH DEVICE LOT # 0808002 LOT # SP100300- 213, IMPLANTED (B)(6) 2016.

  Patient problems: Hernia

  MAUDE report 16138546 ↗
• 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 60 YEAR OLD FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2015. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH, LOT NUMBER SP100232-182, REF NUMBER 0808002. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2021. PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA WITH IRREDUCIBILITY AND UNDERWENT A REMOVAL OF FOREIGN BODY FROM THE TORSO AND OPEN VENTRAL HERNIA REPAIR WITH MESH. THERE WAS INFLAMMATION PRESENT AND THE OMENTUM WAS ADHERED UNDER THE ABDOMINAL WALL, AND OMENTUM AND MESH WERE CUT AWAY AND REMOVED. THE REST OF THE MESH WAS REMOVED AND PATIENT SUSTAINED A FISTULA, RECURRENT HERNIA, ADHESIONS, AND INFECTION.

  Patient problems: Hernia

  MAUDE report 15462997 ↗