Strattice Reconstructive Tissue Matrix Perforated 2025002PRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M3282025002P0), received between Apr 15, 2021 and Feb 20, 2023 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 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 46 YEAR OLD FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT NOVEMBER 11, 2016. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH; LOT # SP100449-207 REF # 2025002P MESH. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6), 2017, FOR A REVISION SURGERY AND ADDITIONAL STRATTICE MESH WAS IMPLANTED (LOT # SP100443-127 REF # 1620002). THIS EVENT IS ASSOCIATED WITH DEVICE LOT SP100449-207. THERE IS NO ALLEGATION OR DATE OF OCCURRENCE REPORTED AFTER THE SECOND DEVICE WAS IMPLANTED AND THEREFORE A RECORD WILL NOT BE OPENED FOR LOT # SP100443-127.

  Patient problems: Hernia

  MAUDE report 16404023 ↗
• InjuryMar 7, 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 MEDICAL DEVICE. AFTER SURGERY, ON OR ABOUT (B)(6) 2016, THE PATIENT WAS DIAGNOSED WITH INFECTION, THE MESH FIXATION WAS REMOVED AND AN ABDOMINAL WALL WASHOUT WAS PERFORMED THEN THE MESH WAS RE-ATTACHED. ON OR ABOUT (B)(6) 2017, THE PATIENT UNDERWENT A REPAIR OF A RECURRENT INCISIONAL HERNIA; IMPLANTATION OF NEW STRATTICE MESH; ADJACENT TISSUE TRANSFER REARRANGEMENT FOR AN AREA OF 25 X 10 CM; LAVAGE AND DRAINAGE OF SURGICAL WOUND; LAYERED CLOSURE OF THE ABDOMINAL WALL AND IMPLANTATION OF DRAIN. ON OR AROUND (B)(6) 2017, THE PATIENT UNDERWENT REPAIR OF RECURRENT HERNIA AND DRAINAGE OF ABDOMINAL ABSCESS. ON OR AROUND (B)(6) 2017, THE PATIENT UNDERWENT A REVISION AND REMOVAL SURGERY OF THE STRATTICE MESH THAT WAS PREVIOUSLY PLACED, INCLUDING SMALL BOWEL RESECTION AND LYSIS OF ADHESIONS. PUS WAS FOUND AT THE MESH SITE AND THERE WERE EXTENSIVE ADHESIONS OF MESH TO BOWEL. THIS RECORD IS ASSOCIATED WITH THE SECOND DEVICE IMPLANTED ON (B)(6) 2017.

  Patient problems: Bacterial Infection; Hernia

  MAUDE report 13685552 ↗
• InjuryMar 3, 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 MEDICAL DEVICE. AFTER SURGERY, ON OR ABOUT (B)(6), 2016, THE PATIENT WAS DIAGNOSED WITH INFECTION, THE MESH FIXATION WAS REMOVED AND AN ABDOMINAL WALL WASHOUT WAS PERFORMED THEN THE MESH WAS RE-ATTACHED. ON OR ABOUT (B)(6), 2017, THE PATIENT UNDERWENT A REPAIR OF A RECURRENT INCISIONAL HERNIA; IMPLANTATION OF NEW STRATTICE MESH; ADJACENT TISSUE TRANSFER REARRANGEMENT FOR AN AREA OF 25 X 10 CM; LAVAGE AND DRAINAGE OF SURGICAL WOUND; LAYERED CLOSURE OF THE ABDOMINAL WALL AND IMPLANTATION OF DRAIN. ON OR AROUND (B)(6) 2017, THE PATIENT UNDERWENT REPAIR OF RECURRENT HERNIA AND DRAINAGE OF ABDOMINAL ABSCESS. ON OR AROUND (B)(6) 2017, THE PATIENT UNDERWENT A REVISION AND REMOVAL SURGERY OF THE STRATTICE MESH THAT WAS PREVIOUSLY PLACED, INCLUDING SMALL BOWEL RESECTION AND LYSIS OF ADHESIONS. PUS WAS FOUND AT THE MESH SITE AND THERE WERE EXTENSIVE ADHESIONS OF MESH TO BOWEL. THIS RECORD IS ASSOCIATED WITH THE FIRST DEVICE IMPLANTED ON (B)(6) 2016.

  Patient problems: Bacterial Infection

  MAUDE report 13663372 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LEGAL, THAT A (B)(6) YEAR OLD MALE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2019 AT (B)(6) HOSPITAL IN (B)(6). THE PATIENT WAS IMPLANTED WITH STRATTICE LOT SP200137-016. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL IN EARLY 2020 AND WAS DIAGNOSED WITH FLUID IN HIS ABDOMEN AND RECURRENT HERNIA. IT HAS BEEN SUGGESTED THAT THE PATIENT HAVE MESH REMOVAL SURGERY.

  Patient problems: Hernia

  MAUDE report 12569006 ↗
• InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2013, (B)(6) 2015, (B)(6) 2016, (B)(6) 2017, (B)(6) 2017 AND (B)(6) 2018. THE PATIENT WAS A FEMALE BETWEEN THE AGES OF 38 AND 43 AT THE TIMES OF SURGERY. THE PATIENT WAS IMPLANTED WITH STRATTICE LOT SP100598-099 DURING THE (B)(6) 2018 PROCEDURE. THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2018 AND (B)(6) 2019. ON (B)(6) 2018, THE PATIENT HAD LYSIS OF ADHESIONS AND REMOVAL OF THE MESH AND A HERNIA REPAIR AT (B)(6) MEDICAL CENTER. ON (B)(6) 2019 THE PATIENT HAD ANOTHER SURGERY REQUIRING ADDITIONAL REMOVAL OF THE STRATTICE MESH AT (B)(6) MEDICAL CENTER. THIS RECORD IS FOR THE LOT SP100598-099 IMPLANTED (B)(6) 2018 (RECORD 6 OF 6).

  Patient problems: Hernia

  MAUDE report 12218258 ↗
• InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT INCISIONAL HERNIA REPAIR WITH STRATTICE MESH (LOT/BATCH: SP100339-159, CATALOG/SERIAL: (B)(4)) IMPLANTED. 3 YEARS LATER, PATIENT RETURNED TO HOSPITAL AND WAS DIAGNOSED WITH INFECTED MESH, REQUIRING REMOVAL. MESH REMOVED THE SAME DAY.

  Patient problems: Unspecified Infection

  MAUDE report 11675393 ↗