Strattice Reconstructive Tissue Matrix 0608001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M32806080010), received between Jul 29, 2022 and Feb 10, 2025 — 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 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP #1 TO REPORT ON 18/FEB/2024, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM (PPF). AS PER THE PPF FORM, THE PATIENT UNDERWENT A REPAIR OF RECURRENT HIATAL HERNIA WITH A REDUCTION OF INTRATHORACIC OMENTUM AND GASTRIC SLEEVE; DIAPHRAGMATIC CRURAL REPAIR REINFORCEDAND AND PATIENT WAS IMPLANTED WITH THE STRATTICE DEVICE LOT# SP100311-133; REF. # 0608001 ON (B)(6) 2016. ON (B)(6) 2016, PATIENT UNDERWENT VENTRAL INCISIONAL HERNIA WITH PRIMARY CLOSURE AND IMPLANTED WITH A NON-ABBVIE DEVICE, ONLAY PHASIX MESH (BARD PHASIX MESH LOT #HUAT2166). ON (B)(6) 2016, A SUBCUTANEOUS SEROMA WAS DRAINED AND SEROSANGUINEOUS FLUID ASPIRATED. THE FORM LISTS THE CONDITION THAT WAS TREATED: ON (B)(6) 2017, AN EXPLORATORY LAPAROTOMY AND SEGMENTAL SMALL BOWEL RESECTION. APPROX. 2016-2017, CAT SCANS OF AB/PEL AND MRI DIAGNOSTIC TESTING PERFORMED. RESULT WAS NOT PROVIDED. BETWEEN (B)(6) 2017, EXPLORATORY LAPAROTOMY AND SEGMENTAL SMALL BOWEL RESECTION PERFORMED. ON (B)(6) 2017, PRESSED FLUID OUT OF SEROMA IN OFFICE POST-OPERATIVELY. BETWEEN (B)(6) 2015 - 2016, FOLLOW UP ON HERNIA SURGERIES REPAIR AND SYMPTOMS. ON (B)(6) 2017, EXPRESSED FLUID (SEROMA FROM BOWEL OBSTRUCTIO

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

  MAUDE report 21343865 ↗
• InjuryJul 18, 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)2013, (B)(6)2014 AND (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. THIS RECORD IS ASSCOCIATED WITH DEVICE 3; IMPLANT DATE (B)(6)2020. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR 1000306051-2023-00164 (ABBVIE COMPLAINT # (B)(4)) AND MDR 1000306051-2023-00162 (ABBVIE COMPLAINT #(B)(4)).

  Patient problems: Hernia

  MAUDE report 17346117 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#2 TO REPORT THAT ON (B)(6) 2023, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT ALTHOUGH A LOT WAS PROVIDED IN THE ORIGINAL SUMMONS, THE VALID LOT ASSOCIATED WITH THIS EVENT WAS FOUND THROUGH DISCOVERY AND IS SP100548-321. NO OTHER INFORMATION WAS REPORTED. AS REPORTED IN INITIAL: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2018. DURING HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH, LOT NUMBER: SP100549. THE RECORDS INDICATE THE DEVICE WAS A STRATTICE MESH. AFTER SURGERY, PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2021, FOR A MESH REVISION OPERATION.

  Patient problems: Hernia

  MAUDE report 16512028 ↗
• InjuryJan 30, 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 54 YEAR OLD FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2020. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH; 6 CM X 8 CM PORCINE MATRIX, LOT # SP00156-439. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2021, FOR A REVISION SURGERY. NO OTHER INFORMATION WAS PROVIDED. ALTHOUGH A LOT NUMBER WAS REPORTED, THE LOT NUMBER IS INVALID AND HAS BEEN UPDATED TO UNKNOWN.

  Patient problems: Hernia

  MAUDE report 16264788 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON 11/MAY/2023, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE LOTS ASSOCIATED WITH THIS EVENT WERE FOUND THROUGH DISCOVERY AND ARE (B)(6), IMPLANT DATE (B)(6) 2019 AND (B)(6), IMPLANT DATE (B)(6) 2020. THIS IS FOLLOW UP#1 TO REPORT THE RESULTS FROM THE INTERNAL INVESTIGATION AND THE CONCLUSION. AS REPORTED IN THE INITIAL: "IT WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2019. DURING HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THE DEVICE WAS A STRATTICE MESH. PATIENT HAD A SUBSEQUENT STRATTICE MESH IMPLANTED DURING A HERNIA REPAIR SURGERY ON (B)(6) 2020. THE RECORDS INDICATE THE DEVICE WAS A STRATTICE MESH. PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THIS RECORD IS FOR THE 2ND STRATTICE MESH."

  Patient problems: Hernia

  MAUDE report 16251008 ↗
• InjuryJul 29, 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 52 YEAR OLD MALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2016. DURING THE HERNIA REPAIR SURGERY THE SURGEON IMPLANTED A STRATTICE MESH. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL, ON OR ABOUT (B)(6) 2020, FOR A REVISION SURGERY.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 15130034 ↗