Strattice Reconstructive Tissue Matrix Laparoscopic 1016005Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M32810160050), received between Apr 25, 2022 and May 5, 2025 — classified as 8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON 13/JUN/2025, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM (PPF) WAS RECEIVED. AS PER THE PPF FORM, THE PATIENT UNDERWENT A VENTRAL INCISIONAL HERNIA SURGERY AND WAS IMPLANTED WITH A STRATTICE DEVICE LOT # SP100007, REFERENCE #1525002 ON (B)(6) 2014. ON (B)(6) 2023 , PATIENT UNDERWENT EXCISION OF THE INFECTED MESH FROM THE HERNIA AND RESECTION OF PART OF THE SMALL BOWEL. PATIENT EXPERIENCED MESH EROSION THROUGH, DENSE SCAR TISSUE AROUND AREA AND FISTULA FORMED BETWEEN THE SMALL BOWEL AND ANOTHER PAT OF THE GASTROINTESTINAL TRACT WITH OPEN WOUND ON THE ABDOMEN THAT WOULD DRAIN AND NEEDING TO BE PATCHED UP. THE FORM LISTS THE CONDITION THAT WAS TREATED: (B)(6) 2003, PLACEMENT OF PROLENE SOFT POLYPROPYLENE MESH. ON (B)(6) 2014, PARTIAL REMOVAL OF PROLENE SOFT POLYPROPYLENE MESH AND PLACEMENT OF STRATTICE MESH. ON (B)(6) 2023, PERFORMED THE REMOVAL OF THE STRATTICE MESH. AS REPORTED IN THE INITIAL: LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE ON (B)(6) 2014. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. THE PATIENT NO

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Fistula; Impaired Healing; Post Operative Wound Infection

  MAUDE report 21960580 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON 21/APR/2025, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM (PPF). AS PER THE PPF FORM, THE PATIENT UNDERWENT A REPAIR OF INCARCERATED INCISIONAL HERNIA AND PATIENT WAS IMPLANTED WITH THE STRATTICE DEVICE LOT# SP200306-054, REF. #1016005 ON (B)(6) 2022. ON (B)(6) 2024, PATIENT UNDERWENT REMOVAL OF OLD MESH AND REPAIR OF COMPLEX INCISIONAL HERNIA WITH TWO NON-ABBVIE DEVICES, SYMBOTEX MESHES WITH MODEL #SYM2520 AND #SYM12. ON (B)(6) 2024, DRAINAGE INTRA-ABDOMINAL ABSCESS, REMOVAL OF MESH, REPAIR RECURRENT INCISIONAL HERNIA WITH 2ND STRATTICE BIOLOGIC MESH WITH UNKNOWN LOT NUMBER AND CATALOG NUMBER 1016002P, WOUND VAC PLACEMENT. ON (B)(6) 2024, SECONDARY WOUND CLOSURE. THE FORM LISTS THE CONDITION THAT WAS TREATED: (B)(6) 2022, REPAIR OF INCARCERATED INCISIONAL HERNIA (STRATTICE). (B)(6) 2024, REMOVAL OF OLD MESH; LYSIS OF ADHESIONS, REPAIR OF COMPLEX INCISIONAL HERNIA WITH TWO SYMBOTEX MESHES. (B)(6) 2024, EXPLORATORY LAPAROTOMY, DRAINAGE OF INTRA-ABDOMINAL ABSCESS, REMOVAL OF MESH, REPAIR RECURRENT INCISIONAL HERNIA WITH STRATTICE BIOLOGIC MESH, WOUND VAC PLACEMENT. (B)(6) 2024, OPEN WOUND OF THE ABDOMEN; SECONDARY WOUND CLOSUR

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

  MAUDE report 21267433 ↗
• InjuryJul 7, 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/AUG/2023, 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 VENTRAL HERNIA REPAIR AND WAS IMPLANTED WITH STRATTICE DEVICE LOT S11289-210 ON (B)(6) 2014. THE PATIENT UNDERWENT AN "EXPLORATORY SURGERY WITH LYSIS OF ADHESIONS AND REMOVAL OF PREVIOUSLY PLACED MESH¿ ON 16/MAR/2023 WHERE THE STRATTICE WAS EXPLANTED AND AS PER THE PPF FORM, A NON-ABBVIE DEVICE, "BARD; VENTRALIGHT ST¿ WAS IMPLANTED. NO ¿REVISION¿ OR ¿REMOVAL¿ WAS REPORTED FOR THE NON-ABBVIE DEVICE. THE FAILURE OF THE STRATTICE MESH CAUSED CHRONIC PAIN, AND ADHESIONS, WHICH REQUIRED AN ADDITIONAL SURGICAL PROCEDURE DURING WHICH THE STRATTICE WAS REMOVED. NO OTHER INFORMATION WAS REPORTED. THE EVENT OF ¿REHERNIATION¿ WAS REMOVED AS THIS EVENT DID NOT REPORT A RECURRENCE WITH STRATTICE. AS REPORTED IN THE INITIAL: LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE LAPAROSCOPIC ON (B)(6) 2014. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION WAS PROVIDED ON THE INDICATI

  Patient problems: Adhesion(s); Hernia

  MAUDE report 17278810 ↗
• InjuryDec 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 53 YEAR OLD MALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2012. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THIS IS A STRATTICE RECONSTRUCTIVE TISSUE MESH. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2014, FOR A REVISION SURGERY. DURING THE REVISIONS SURGERY, THE SURGEON IMPLANTED A SECOND STRATTICE MESH. THE RECORDS INDICATE THIS IS A STRATTICE RECONSTRUCTIVE TISSUE MESH. THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2015, FOR AN ADDITIONAL REVISION SURGERY. THIS RECORD IS ASSOCIATED WITH THE SECOND DEVICE IMPLANTED ON (B)(6) 2014, LOT UNKNOWN.

  Patient problems: Hernia

  MAUDE report 16036020 ↗
• InjuryMay 6, 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) 2015. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH LOT SP100151-096. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2016 AND WAS DIAGNOSED WITH A RECURRENT HERNIA. ON OR ABOUT (B)(6) 2016 THE PATIENT UNDERWENT A MESH REVISION OPERATION. AS PART OF THE REVISION SURGERY, THE SURGEON IMPLANTED ANOTHER STRATTICE MESH, LOT NO. SP100288-057. FOLLOWING THE REVISION SURGERY, THE PATIENT AGAIN RETURNED TO THE HOSPITAL ON (B)(6) 2016, WHERE THE PATIENT WAS DIAGNOSES WITH A RECURRENT INCARCERATED VENTRAL HERNIA. ON (B)(6) 2016, THE SURGEON IMPLANTED A THIRD STRATTICE MESH, LOT NO. SP100503-132. THIS RECORD IS ASSOCIATED WITH THE FIRST DEVICE IMPLANTED ON (B)(6) 2015, LOT SP100151-096. AS PER THE REPORTED INFORMATION, THERE IS NO COMPLAINT AGAINST DEVICE LOT SP100503-132.

  Patient problems: Hernia

  MAUDE report 14305223 ↗
• InjuryMay 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) FEMALE PATIENT UNDERWENT A RECURRENT VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2016 AT (B)(6). DURING THE SURGERY, THE SURGEON IMPLANTED TWO STRATTICE MESHS: LOTS SP100398-178 AND SP100393-230. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6), 2017 BECAUSE OF PAIN AND SWELLING TO HER LATERAL ABDOMEN. SHE HAD A PARTIALLY REDUCIBLE HERNIA CONTAINING SMALL BOWEL AND THE SEROSA WAS INTIMATELY INVOLVED WITH THE STRATTICE. ON (B)(6), 2017 THE PATIENT UNDERWENT A REVISION SURGERY PERFORMED BY THE SAME IMPLANTING PHYSICIAN. IT SHOULD BE NOTED THAT AS PER LEGAL, THE COMPLAINT LISTS SP100393-230 AS ONE OF THE LOT NUMBERS, BUT THEY DETERMINED THROUGH DISCOVERY THAT THE CORRECT LOT NUMBER IS SP100529-283. THIS RECORD IS ASSOCIATED WITH LOT SP100529-283.

  Patient problems: Hernia

  MAUDE report 14270267 ↗
• InjuryMay 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) FEMALE PATIENT UNDERWENT A RECURRENT VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2016 AT (B)(6). DURING THE SURGERY, THE SURGEON IMPLANTED TWO STRATTICE MESHS: LOTS SP100398-178 AND SP100393-230. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2017 BECAUSE OF PAIN AND SWELLING TO HER LATERAL ABDOMEN. SHE HAD A PARTIALLY REDUCIBLE HERNIA CONTAINING SMALL BOWEL AND THE SEROSA WAS INTIMATELY INVOLVED WITH THE STRATTICE. ON (B)(6), 2017 THE PATIENT UNDERWENT A REVISION SURGERY PERFORMED BY THE SAME IMPLANTING PHYSICIAN. IT SHOULD BE NOTED THAT AS PER LEGAL, THE COMPLAINT LISTS SP100393-230 AS ONE OF THE LOT NUMBERS, BUT THEY DETERMINED THROUGH DISCOVERY THAT THE CORRECT LOT NUMBER IS SP100529-283. THIS RECORD IS ASSOCIATED WITH LOT SP100398-178.

  Patient problems: Hernia

  MAUDE report 14270128 ↗
• InjuryApr 25, 2022Adverse 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 (B)(6) MALE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2014. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A LIFECELL STRATTICE MESH STRATTICE AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2015, WAS DIAGNOSED WITH A RECURRENT HERNIA AND UNDERWENT A MESH REVISION OPERATION.

  Patient problems: Hernia

  MAUDE report 14192257 ↗