Strattice Reconstructive Tissue Matrix 3030002Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M32830300020), received between Nov 2, 2018 and Nov 26, 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.

• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 17/NOV/2025, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. THIS RECORD CAPTURES THE 3RD STRATTICE DEVICE. AS PER THE PPF FORM, THE PATIENT UNDERWENT AN ¿INCISIONAL HERNIA¿ SURGERY AND WAS IMPLANTED WITH STRATTICE DEVICES LOTS ¿SP200471-041,¿ ¿SP200503-106,¿ AND ¿SP200531-007¿ ON (B)(6) 2023. THE PATIENT UNDERWENT A ¿REPAIR OF RECURRENT DEFECT DUE TO NON ADHERENCE OF PRIOR MESH, REMOVAL OF OLD STRETCHED MESH¿ ON (B)(6) 2024 AND REPLACED WITH A NON-ABBVIE DEVICE, ¿BARD PHASIX ST - REF: (B)(4). THE FORM LISTS THE CONDITIONS THAT WERE TREATED WERE ¿LONG INFECTION, ABSCESS, EXTENSIVE HOSPITALIZATION, SEROMA, PAIN¿ BETWEEN (B)(6) 2023 AND (B)(6) 2025. THE PATIENT WAS THEN TREATED FOR ¿MRSA INFECTION¿ BETWEEN (B)(6) 2023. THE PATIENT RECEIVED TREATMENT FOR ¿INFECTION, PAIN, FEVER, ABDOMINAL WALL FLUID COLLECTION¿ BETWEEN (B)(6) 2023. THE PATIENT RECEIVED ¿PAIN MANAGEMENT¿ FROM 2024-2025. THE PPF FORM ALSO INDICATES THAT THE PATIENT WAS IMPLANTED WITH A NON-ABBVIE DEVICE, ¿BARD PHASIX ST - REF: (B)(4),¿ ON (B)(6) 2024. THE FORM DOES NOT INDICATE WHETHER THIS DEVICE WAS REMOVED OR REVISED. THE PLAINTIFF ALSO SOUGHT TREATMEN

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

  MAUDE report 23658966 ↗
• InjuryOct 5, 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 AND (B)(6) 2017. 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 ON (B)(6) 2017. ADDITIONAL INFORMATION WAS RECEIVED THROUGH THE PPF FORM THAT STATES: THE UNDERWENT A SURGERY FOR A VENTRAL HERNIA AND THE PATIENT WAS IMPLANTED WITH LOT #SP100458-095. FROM POST (B)(6) 2017 THE PATIENT WAS TREATED FOR "WOUND CARE INCLUDING WOUND VAC; RECOVERY FROM EXTENSIVE ABDOMINAL SURGERY/OPEN VENTRAL HERNIA REPAIR; PT/OT". ON (B)(6) 2017, THE CONDITION TREATED IS LISTED AS "INCREASED PAIN DIFFUSELY; ABDOMINAL PAIN; DRAINS FELL OUT AND SEROUS DRAINAGE FROM RIGHT LOWER DRAIN; NAUSEA AND VOMITING; FEVER; ABSCESS; GIVEN IV ANTIBIOTICS" ON (B)(6) 2017, THE PATIENT UNDERWENT A "CT GUIDANCE FOR NEEDLE PLACEMENT; ABDOMINAL WALL ABSCESS DRAINAGE WITH INTERPRETATION". THE PATIENT CLAIMS THE FOLLOWING RESULTED FROM THE IMPLANTATION OF THE STRATTICE MESH: THE PATIENT HAS EXPERIE

  Patient problems: Bacterial Infection

  MAUDE report 17878966 ↗
• InjuryApr 25, 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 64 YEAR OLD PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT ON (B)(6) 2014. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED TWO STRATTICE MESHES; LOT#: S11253-091; REF#: (B)(4); MESH AND LOT#: S1273-014 ;REF#: (B)(4). AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT ON (B)(6) 2014, FOR A REVISION AND REMOVAL SURGERY. NO OTHER INFORMATION WAS PROVIDED. THIS RECORD IS ASSOCIATED WITH THE SECOND DEVICE IMPLANTED, S1273-014 ; REF#: (B)(4); HOWEVER THIS IS NOT A VALID LOT NUMBER AND HAS BEEN DEFAULTED TO UNKNOWN. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR#: 1000306051-2023-00087 (ABBVIE COMPLAINT#: (B)(4).

  Patient problems: Hernia

  MAUDE report 16811417 ↗
• InjuryAug 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 69 YEAR OLD FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2017. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH; CATALOG NUMBER IS 3030002 AND LOT NUMBER IS SP100503-242. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2021, REPORTING SHARP AND CUTTING PAIN, NAUSEA, AND HAVING TO CONSISTENTLY WEAR ABDOMINAL BINDERS. ON OR ABOUT (B)(6) 2021, THE PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN AND A RECURRENT HERNIA AND UNDERWENT AN EXPLORATORY LAPAROTOMY, EXCISION OF OLD MESH AND ABDOMEN CLOSURE. UPON SURGICAL DISSECTION, THE SURGEON NOTED FAILURE OF THE MESH TO INCORPORATE INTO THE TISSUE. THE MESH WAS FOUND ADHERED TO A FEW SPOTS IN THE LEFT UPPER ABDOMEN. THE MESH WAS FOLDED MULTIPLE TIMES AND WRINKLED CLOSE TO THE AREA WHERE SHE WAS EXPERIENCING SEVERE PAIN.

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

  MAUDE report 15158083 ↗
• InjuryFeb 23, 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) WOMEN UNDERWENT HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2015. THE SURGEON PERFORMED THE RECURRENT INCARCERATED MIDLINE AND INCISIONAL HERNIA REPAIR AT THE MEDICAL CENTER (B)(6). DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH IN THE PATIENT. THE RECORDS INDICATE IT WAS STRATTICE MESH ITEM 3030002, LOT SP100244-319. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2016 FOR A MESH EXPLANT SURGERY AT THE MEDICAL CENTER (B)(6).

  Patient problems: Hernia

  MAUDE report 13588029 ↗
• InjuryNov 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PATIENT THROUGH VOLUNTARY MW5079828 THAT FOLLOWING IMPLANT WITH ONE STRATTICE 30X30 HERNIA MESH ON (B)(6) 2015, THEY DEVELOPED SEVERE PAIN AND HAD AN INFECTION WHICH RESULTED IN THE INCISION REOPENED TO REMOVE THE INFECTION, FOLLOWED BY WOUND VAC THERAPY FOR SEVERAL MONTHS. THE FOLLOWING YEAR, THE PATIENT REPORTED TO STILL HAVE SEVERE ABDOMINAL PAIN WHICH LED TO A BOWEL OBSTRUCTION AND THEN ABSCESS DRAINAGE, BOTH IN 2017. THE PATIENT STILL EXPERIENCES MORE ABDOMINAL PAIN RESULTING IN THE RETURN OF THREE HERNIAS, TWO IN THE GROIN AND ONE IN THE ABDOMINAL AREA. THE PATIENT IS AWAITING REVISION SURGERY FOR ALL OF THE HERNIAS IN 2018. IT WAS CONFIRMED THAT THIS WAS NOT REPORTED TO LIFECELL AS A COMPLAINT AT THE TIME OF EVENT BY "NEITHER" THE PATIENT "NOR" THEIR HEALTH CARE PROFESSIONAL.

  Patient problems: Abdominal Pain; Hernia; Unspecified Infection

  MAUDE report 8032287 ↗