Strattice Reconstructive Tissue Matrix Laparoscopic 2020005Recalls & reported problems
Lifecell Corporation · Strattice Laparoscopic 20cm x 20cm · Class 2 · Implant
Data updated Oct 13, 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 M32820200050), received between Jun 29, 2023 and Jun 29, 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Adhesion(s)1
- Hernia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS IS FOLLOW UP#1 TO REPORT ON 30/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 ON (B)(6)2013 AND WAS IMPLANTED WITH STRATTICE MESH DEVICE LOT S11221-052. THE PATIENT THEN UNDERWENT A ¿REPAIR OF RECURRENT VENTRAL HERNIA LYSIS OF ADHESIONS¿. THE PATIENT CLAIMS THE IMPLANTATION AND FAILURE OF THE STRATTICE MESH HAS ¿CAUSED CHRONIC PAIN, ADHESIONS AND HERNIA RECURRENCE WHICH REQUIRED AN ADDITIONAL SURGICAL PROCEDURE.¿ THE PPF FORM ALSO INDICATES THE PATIENT WAS IMPLANTED WITH ANOTHER STRATTICE DEVICE, LOT SP100006-029 DURING THE (B)(6)2014; HOWEVER NO ¿REVISION OR REMOVAL¿ SURGERY WAS REPORTED. NO OTHER INFORMATION AS PROVIDED. SINCE THERE IS NO ¿REVISION OR REMOVAL¿ SURGERY FOR THE SECOND DEVICE, A COMPLAINT RECORD WILL NOT BE OPENED FOR LOT SP100006-029. AS REPORTED IN THE INITIAL: LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE (B)(6) 2013. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION WAS PROVIDED ON THE INDICATIO
Patient problems: Adhesion(s); Hernia
MAUDE report 17226608 ↗
Other Mesh, Surgical devices
- MEDPOR TITAN 81032Stryker Leibinger GmbH & Co. KG · Mesh, surgical1 recall1 report
- Peri-Guard PC1016NSynovis Life Technologies, Inc. · Mesh, surgical1 recall1 report
- Supple Peri-Guard SPG0404Synovis Life Technologies, Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-403-001Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-006Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-019Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-001-009Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-004-105Tei 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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