Strattice Reconstructive Tissue Matrix 2040002Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M32820400020), received between Jan 25, 2019 and Jul 12, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 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 68 YEAR OLD PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2015. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH; MODEL/CATALOG NUMBER IS 2040002 AND THE LOT NUMBER IS SP100235-204. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2017 AND WAS DIAGNOSED WITH A RECURRENT INCISIONAL HERNIA AND UNDERWENT A REPAIR OF AN ABDOMINAL WALL HERNIA AND LYSIS OF ADHESIONS. THE BIOLOGIC MESH WAS NOTED TO HAVE DEGRADED AND REABSORBED, AND THERE WERE MULTIPLE LOOPS OF BOWEL WITHIN THE RECURRENT HERNIA. THE HERNIA WAS REPAIRED WITH THE PLACEMENT OF ADDITIONAL MESH. ON OR ABOUT (B)(6) 2018, THE PRESENTED WITH PAIN, SWELLING, AND DRAINAGE AT THE SITE OF THE VENTRAL HERNIA REPAIR FROM AUGUST 2017 AND UNDERWENT AN INCISION AND DEBRIDEMENT FOR ABDOMINAL ABSCESS AND HAD A WOUND VAC PLACED. THIS RECORD IS ASSOCIATED WITH SP100235-204, RECORD 1 OF 2.

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

  MAUDE report 14989995 ↗
• InjuryApr 19, 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 HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2011. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED TWO STRATTICE MESHES. THE RECORDS INDICATE THESE WERE A STRATTICE FIRM 16 X 20 AND STRATTICE FIRM 6 X 16 MESH. AFTER SURGERY, THE PATIENT HAD SEVERAL REVISION SURGERIES INCLUDING: (B)(6) 2012, DURING WHICH A STRATTICE FIRM 10 X 16 MESH WAS IMPLANTED, (B)(6) 2014, REVISION SURGERY DURING WHICH A STRATTICE FIRM 16 X 20 MESH WAS IMPLANTED AND (B)(6) 2015, SURGERY DURING WHICH A STRATTICE FIRM 20 X 40 MESH WAS IMPLANTED. THIS RECORD IS ASSOCIATED WITH THE FIFTH STRATTICE FIRM 20 X 40 MESH IMPLANTED ON (B)(6) 2015. RECORD 4 OF 5.

  Patient problems: Hernia

  MAUDE report 14147978 ↗
• InjuryJan 25, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  HEALTHCARE PROFESSIONAL REPORTED THE "PATIENT WAS BEING EXTUBATED AND BEGAN TO COUGH. THE PHYSICIAN HEARD A POP AND COULD SEE THAT THE MESH BECAME DISLODGED" AND "THE SUTURE BASICALLY CHEESE WIRED THROUGH THE PRODUCT AND FAILED IN 3-4 LOCATIONS." STRATTICE WAS REMOVED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 8277338 ↗