Strattice Reconstructive Tissue Matrix Perforated 2540002PRecalls & reported problems
Lifecell Corporation · Strattice Reconstructive Tissue Matrix Perforated 25 x 40 cm rectangle · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M3282540002P0), received between Jun 26, 2023 and Jun 26, 2023 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hernia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 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 26/JUL/2023, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. AS PER THE PPF FORM, THE PATIENT WAS IMPLANTED WITH STRATTICE DEVICE LOT SP100464-010, REF# 2540002P ON (B)(6) 2017. THE PATIENT UNDERWENT A "REPAIR OF RECURRENT VENTRAL HERNIA" ON (B)(6) 2018. ADDITIONAL INFORMATION STATES "THE FAILURE OF THE MESH CAUSED CHRONIC PAIN AND A HERNIA RECURRENCE WHICH REQUIRED AN ADDITIONAL SURGICAL PROCEDURE. THE PATIENT CONTINUES TO EXPERIENCE SYMPTOMS, INCLUDING, BUT NOT LIMITED TO, PAIN AND DISCOMFORT AS A RESULT OF THE RECURRENCE CAUSED BY THE FAILURE OF THE STRATTICE HERNIA MESH IMPLANT." THE FORM LISTS THE PATIENT WAS TREATED FOR "HERNIA RECURRENCE", "SEVERE PAIN", AND ¿ALL OTHER CONDITIONS IDENTIFIED" WITH APPROXIMATE DATES OF TREATMENT IN 2018 AND 2020. THE PPF FORM ALSO INDICATES THE PATIENT WAS IMPLANTED WITH ANOTHER NON-ABBVIE DEVICE, BARD: PHASIX ON (B)(6) 2022 AND WAS TREATED FOR "HERNIA RECURRENCE¿, ¿SERVE PAIN¿, IN APPROXIMATELY 2022. THE INITIAL REPORT INADVERTENTLY STATED THE FIRST DEVICE IMPLANT DATE WAS (B)(6) 2018; HOWEVER THE CORRECT DATE ASSOCIATED WITH THE FIRST DEVICE IMPLA
Patient problems: Hernia
MAUDE report 17198115 ↗
Other Mesh, Surgical devices
- Peri-Guard PC1016NSynovis Life Technologies, Inc. · Mesh, surgical1 recall1 report
- MEDPOR TITAN 81032Stryker Leibinger GmbH & Co. KG · Mesh, surgical1 recall1 report
- SurgiMend® 606-300-006Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-019Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-400-009Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-020Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-003-001Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-003-002Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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