Strattice Reconstructive Tissue Matrix 2540002Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M32825400020), received between Jul 6, 2021 and Aug 27, 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.

• InjuryAug 27, 2025Adverse 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 1ST STRATTICE AND 2ND STRATTICE FIRM ON (B)(6) 2023. 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 IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6) (EMDR- (B)(4) ). THIS EMDR IS BEING SUBMITTED FOR THE 2ND STRATTICE FIRM.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Post Operative Wound Infection; Seroma

  MAUDE report 22903559 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON 21/AUG/2024, 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 INCARCERATED INCISIONAL HERNIA SURGERY AND WAS IMPLANTED WITH A STRATTICE DEVICE LOT UNKNOWN AND CATALOG NUMBER 2540002 ON (B)(6) 2016. ON (B)(6) 2017, PATIENT UNDERWENT AN EXPLORATORY LAPAROSCOPY, RESECTION OF UMBILICAL INCISIONAL HERNIA WITH MESH FROM PERIUMBILICAL REGION. ON (B)(6) 2021, PATIENT UNDERWENT ROBOTIC REPAIR OF VENTRAL HERNIA WITH MESH, RIGHT-SIDED TRANSVERSES ABDOMINIS RELEASE. AS PER THE PPF FORM, THE PATIENT CLAIMS: PAIN AND SUFFERING, PHYSICAL INJURY, LOSS OF ENJOYMENT OF LIFE, ECONOMIC AND NON-ECONOMIC LOSSES AS A RESULT OF HER STRATTICE IMPLANT. PATIENT SUFFERS FROM ABDOMINAL TENDERNESS. PATIENT IS DEPENDENT ON OTHERS TO HELP WITH DAILY TASKS, HAS DIFFICULTY COMPLETING THEM. PATIENT HAD LIFTING RESTRICTIONS AND HAD TO ADJUST PHYSICAL ACTIVITIES. PATIENT HAS DIFFICULTY DRIVING FOR LONG PERIODS OF TIME AND WALKING LONG DISTANCES. THEY HAVE DIFFICULTY SLEEPING, WEARS AN UNCOMFORTABLE COMPRESSION BINDER AND STOMACH IS SCARRED AND DISFIGURED CAUSING EMBARRASSMENT. THE

  Patient problems: Adhesion(s); Hernia

  MAUDE report 19751135 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 01/FEB/2024, LEGAL RECEIVED LIMITED INFORMATION THAT A PATIENT WAS IMPLANTED WITH STRATTICE ON (B)(6) 2019. ON 09/APR/2024, 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 STRATTICE DEVICE ON (B)(6) 2019. THE PATIENT UNDERWENT A ¿REPAIR OF RECURRENT INCISIONAL HERNIA USING 25 X 20 CM PHASIX MESH, EXTENSIVE LYSIS OF ADHESION; APPLICATION OF PREVENA VAC¿ ON (B)(6) 2022. THE PATIENT ALSO UNDERWENT A ¿REPAIR OF RECURRENT INCISIONAL HERNIA USING 30 X 25 CM PHASIX MESH, EXTENSIVE LYSIS OF ADHESION, APPLICATION OF PREVENA VAC, CREATION OF BILATERAL SUBCUTANEOUS FLAPS¿ ON (B)(6) 2023. AS PER THE PPF FORM, THE PATIENT CLAIMS THE IMPLANTATION AND FAILURE OF THE MESH CAUSED ¿PAIN AND SUFFERING, PHYSICAL INJURY, LOSS OF ENJOYMENT OF LIFE, AND ECONOMIC AND NON-ECONOMIC LOSSES AS A RESULT OF [THEIR] STRATTICE IMPLANT.¿ PATIENT ¿SUFFERS FROM ABDOMINAL PAIN AND DISCOMFORT.¿ PATIENT "HAS BEEN HOSPITALIZED AND UNDERGONE MULTIPLE SURGICAL PROCEDURES.¿ PATIENT ¿IS DEPENDENT ON OTHERS TO HELP WITH DAILY TASKS [THEY HAVE] DIFFICULTY COMPLETING

  Patient problems: Adhesion(s); Fluid Discharge; Hernia

  MAUDE report 19101521 ↗
• InjuryAug 30, 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) 2014 AND (B)(6) 2015. 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 ASSOCIATED WITH THE DEVICE IMPLANTED (B)(6) 2015. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR # 1000306051-2023-00182 (ABBVIE COMPLAINT # (B)(4)).

  Patient problems: Hernia; Unspecified Infection

  MAUDE report 17653399 ↗
• InjuryNov 1, 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 55 YEAR OLD FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2012. DURING THE INCISIONAL HERNIA REPAIR SURGERY, THE SURGEON, DR. THOMAS TOMASIK, AT NORTHWESTERN MEDICINE, IMPLANTED A STRATTICE MESH, CATALOG NO. 2540002. AFTER SURGERY, THE PATIENT RETURNED TO NORTHWESTERN MEDICINE ON OR ABOUT (B)(6) 2013 AND WAS DIAGNOSED WITH A LARGE ABDOMINAL RECURRENT INCISIONAL HERNIA AND WAS REPORTING PAIN. ON OR ABOUT (B)(6) 2013, PATIENT UNDERWENT A RECURRENT INCISIONAL HERNIA REPAIR AND LYSIS OF ADHESIONS WITH THE PLACEMENT OF ADDITIONAL STRATTICE MESH, CATALOG NO. 2030002.

  Patient problems: Hernia

  MAUDE report 15707399 ↗
• InjuryJul 18, 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 70 YEAR OLD FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2014. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE 2540002 FIRM MESH. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2016, REPORTING ABDOMINAL PAIN AND WAS DIAGNOSED WITH A LARGE LOWER ABDOMINAL HERNIA. ON OR ABOUT (B)(6) 2016, THE UNDERWENT A RECURRENT INCISIONAL HERNIA REPAIR WITH MESH AND LEFT MUSCLE TRANSFER FLAP. ON OR ABOUT (B)(6) 2019, THE PRESENTED BACK TO THE HOSPITAL AND WAS DIAGNOSED WITH A RECURRENT VENTRAL HERNIA. SHE UNDERWENT A REPAIR OF A RECURRENT INCARCERATED INCISIONAL HERNIA WITH MESH AND LYSIS OF ADHESIONS. THIS RECORD IS ASSOCIATED WITH THE DEVICE IMPLANTED ON (B)(6) 2014.

  Patient problems: Hernia

  MAUDE report 15041895 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD MALE PATIENT UNDERWENT A HERNIA REPAIR ON (B)(6) 2016 AT (B)(6) IN (B)(6) AND WAS IMPLANTED WITH STRATTICE LOT SP100442-201. AFTER THE SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2019 AND WAS DIAGNOSED WITH AN ACUTE SMALL BOWEL OBSTRUCTION WITH INCARCERATED HERNIA REQUIRING REMOVAL OF THE STRATTICE MESH AT (B)(6).

  Patient problems: Hernia; Obstruction/Occlusion

  MAUDE report 12124588 ↗